DISCOVER NEW HORIZONS IN FLUID DRAINAGE. Bringing Safety and Convenience to Fluid Drainage Management

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1 DISCOVER NEW HORIZONS IN FLUID DRAINAGE Bringing Safety and Convenience to Fluid Drainage Management

2 DRAIN ASEPT Pleural and Peritoneal Drainage Catheter System 600mL or 1,000mL Evacuated Drainage Bottle 2,000mL Drainage Bag Palliative, Compassionate, and Convenient Patient Care For Long-Term, Intermittent Drainage of Symptomatic, Recurrent Pleural Effusions and Malignant Ascites Needle-Free Swabable Self-Sealing Valve Secure, Needle-Free Universal Luer Lock Connection System Large Fenestrated Catheter Drain Holes Catheter Retention Cuff Replacement Valve Eliminates the Exchange of Entire Catheter System Evacuated Drainage Bottle Manufactured with NON-GLASS, Shatterproof, Medical Grade Plastic for Safe and Secure, Needle-Free Containment of Biohazardous Fluids Optional 2,000mL Drainage Bag for Peritoneal Drainage 2

3 ASEPT Pleural and Peritoneal Drainage Catheter System Catheter Luer Lock Connection The ASEPT Drainage System is a complete insertion kit for pleural or peritoneal catheter implantation. The primary component of the ASEPT Drainage System is the catheter, which has a self-sealing valve attached to the proximal end that prevents leakage and provides a secure, Needle-Free Luer Lock connection. The ASEPT valve can be connected to the ASEPT Drainage Line on the ASEPT Evacuated Drainage Bottle. The ASEPT Drainage Line sets are also available as stand-alone items to allow drainage to compatible drainage collection units. Kit Contents: TRAY 2: PROCEDURE TRAY 3: POST PROCEDURE Two - 5cc Syringes One - Synthetic Suture, 2-0 One - ASEPT 15.5F Drainage Catheter One - 10cc Syringe Straight Needle One - CSR Wrap One - 22 Ga x 1.5 Needle One - Synthetic Suture, 3-0 One - 25 Ga x 1.0 Needle Curved Needle TRAY 1: PREP One - 18 Ga Guidewire One - 16 Ga x 1.0 Needle One - Pkg. Povidone Iodine Swabs Introducer Needle One - 5-in-1 Drainage Line Adapter Two - Scrub Sponges with Handle One x 70cm J-Tip Guidewire One - ASEPT Drainage Line with One - Fenestrated Drape One - Safety Scalpel Protective Cap One - 16F Tear Away Introducer One - Foam Catheter Pad One - 12F Dilator Six - Gauze Pads 4 x 4 One - 8F Dilator One - Self-Adhesive Dressing One - Tunneler One - Forceps ASEPT Valve Spin-Lock Male Luer Drainage Line ASEPT Evacuated Drainage Bottles and 2,000mL Drainage Bag The primary components of the ASEPT Drainage Kit are the evacuated bottle or bag and the Procedure Pack with all the necessary dressing change items. The evacuated bottle is available in either a 600mL or 1,000mL configuration. The ASEPT Drainage Kit provides patients with a convenient and compassionate way to perform drainage at home or in any outpatient setting. Drainage Line Drainage Drainage Line Procedure Pack Green Vacuum Indicator Blue Three Foam Six Four Gloves Self-Adhesive Emergency Alcohol Catheter Gauze Dressing Slide Pads Pad Pads Fluid Release Valve 600mL Bottle 1,000mL Bottle 2,000mL Drainage Bag ASEPT Pleural Drainage System (Includes ASEPT Pleural Drainage Catheter and Insertion Kit) Accessories: ASEPT Peritoneal Drainage System (Includes ASEPT Peritoneal Drainage Catheter and Insertion Kit) ASEPT 600mL Drainage Kit (Includes ASEPT 600mL Evacuated Bottle with Drainage Line and Procedure Pack) ASEPT 1,000mL Drainage Kit (Includes ASEPT 1,000mL Evacuated Bottle with Drainage Line and Procedure Pack) ASEPT 2,000mL Drainage Bag with Drainage Line ASEPT 2,000mL Drainage Bag Kit (Includes ASEPT 2,000mL Drainage Bag with Drainage Line and Procedure Pack) DRAIN ASEPT Replacement Valve ASEPT Drainage Line Set ASEPT Replacement Valve ASEPT Drainage Line Set (Includes Drainage Line with Protective Cap, Spin-Lock Luer Connector, 5-in-1 Adapter, and )

4 ASEPT 600mL and 1,000mL EVACUATED Drainage Bottles GLASS-FREE Manufactured with NON-GLASS, Shatterproof, Medical Grade Plastic for Safe and Secure, Needle-Free Containment of Biohazardous Fluids Reduction of Hazardous Waste Costs vs. Evacuated Glass Containers Available with a Valved, Y-site Drain Line for Sampling or without Drain Line for Direct, Needle-Free Closed-System Connection Each ASEPT EVACUATED Drainage Bottle Is Available Individually Packaged (Sterile Field Use) or without Individual Packaging (Sterile Fluid Pathway Only) Not Made with DEHP Compatible with ASEPT Pleural and Peritoneal Drainage Catheter System ACCEL Centesis Catheter ACCEL Connection Sets Other Drainage Collection Devices Utilizing Standard Luer Connections 4

5 ASEPT 600mL and 1,000mL EVACUATED Drainage Bottle with Y-site Sampling Port and Drain Line (Individually Packaged) ASEPT 600mL and 1,000mL EVACUATED Drainage Bottle without Drain Line (Available with or without Individual Packaging) Drain Line Needle-Free Luer Y-site Sampling Port Vacuum Release Slide Green Vacuum Indicator MADE OF MEDICAL GRADE PLASTIC Needle-Free Luer Connection and Sampling Port with Protective Cap Vacuum Release Slide Needle-Free Luer Connection and Sampling Port Green Vacuum Indicator Spin-Lock Male Luer Connector Bare Drainage Bottle without Individual Packaging (Sterile Fluid Pathway Only) Drainage Bottle Individually Packaged (Sterile Field Use) *ASEPT 600mL Evacuated Drainage Bottle with Y-site Sampling Port and Drain Line M *ASEPT 600mL Evacuated Drainage Bottle without Drain Line *ASEPT 1,000mL Evacuated Drainage Bottle with Y-site Sampling Port and Drain Line M *ASEPT 1,000mL Evacuated Drainage Bottle without Drain Line *Individually Packaged (Sterile Field Use) ASEPT 600mL Bare Evacuated Drainage Bottle without Individual Packaging Sterile Fluid Pathway Only B 10 ASEPT 1,000mL Bare Evacuated Drainage Bottle without Individual Packaging Sterile Fluid Pathway Only B 10 *Individually Packaged (Sterile Field Use) DEHP Not made with DEHP 5

6 B. Braun Interventional Systems 600mL and 1,000mL EVACUATED Drainage Bottle GLASS-FREE Manufactured with NON-GLASS, Shatterproof, Medical Grade Plastic for Safe and Secure, Needle-Free Containment of Biohazardous Fluids The 600mL Evacuated Drainage Bottle has a Universal, Needle-Free Female Luer Lock Connection Bottle Features Tapered Sides for Easy Handling Large Vacuum Indicator Adjustable Hanging Strap Not Made with Natural Rubber Latex, DEHP, or PVC Compatible with ACCEL Centesis Catheter ACCEL Connection Sets Other Drainage Collection Devices Utilizing Standard Luer Connections 6

7 600mL EVACUATED Drainage Bottle The 600mL Drainage Bottle Contains the Following Items: MADE OF MEDICAL GRADE PLASTIC Removable Adjustable Hanging Strap with Locking Mechanism One 600mL Vacuum Bottle Bottle Scaled in 50mL Increments Green Vacuum Indicator Needle-Free Female Luer Lock Connection Vacuum Release Slide Adjustable Hanging Strap Crystal Clear Transparent Material Individually Packaged for Sterile Field Use 600mL Evacuated Drainage Bottle Individually Packaged, Sterile Field Use Female Luer Lock Connection Green Vacuum Indicator Vacuum Release Slide LATEX DEHP Not made with DEHP Not made with natural rubber latex PVC Not made with PVC 7

8 ASEPT 2,000mL Drainage Bag For Fast and Easy Drainage with the ASEPT Peritoneal Drainage Catheter System ACCEL Centesis Catheter Percutaneous Fluid Drainage For Short-Term Fluid Drainage UNIVERSAL 600mL Drainage Bag Versatility Flex-Ability Durability 8

9 ACCEL Connection Sets Kink-Resistant Tubing for the Aspiration, Removal, or Sampling of Body Fluids Using an External Vacuum Source Length Pack Length Pack SPIN-LOCK SET: Two Spin-Lock Male Luer Connectors with and Non-Vented Spike in. (130cm) approx. 50 CLOSED MALE SET: Closed Male Luer Lock Valve to Spin-Lock Male Luer Connector with in. (130cm) approx. 50 Two Spin-Lock Male Luer Connectors ors Closed Self-Sealing Male Luer Lock Valve Kink-Resistant Clear Tubing Spin-Lock Male Luer Connector Kink-Resistant Clear Tubing Spin-Lock Male Luer Connector Non-Vented Spike Length Pack SPLIT CLOSED MALE SET: Bifurcated Set with Two Closed Male Luer Lock Valves to Spin-Lock Male Luer Connector with in. (122cm) approx. 50 Two Closed Self-Sealing Male Luer Lock Valves Kink-Resistant Clear Tubing Spin-Lock Male Luer Connector LATEX Not made with natural rubber latex DEHP Not made with DEHP 11

10 ACCEL Connection Sets Split Closed Male Luer, Spin-Lock Male Luer, and Closed Male Luer product inuse photo here Josh to help with this in studio set-up. Kink-Resistant Tubing for Aspiration, Removal, or Sampling of Body Fluids Using an External Vacuum Source Closed Male Luer Lock Valve Sets Provide for a Safe and Secure, Closed-System Connection Containing Biohazardous Fluids during and after Use Split Closed Male Luer Lock Valve Set Provides for a Safe and Secure, Closed-System Connection Using Two Evacuated Drainage Bottles or Other Compatible Drainage Collection Devices Not made with Natural Rubber Latex or DEHP Compatible with ASEPT Pleural and Peritoneal Drainage Catheter System 600mL and 1,000mL Evacuated Drainage Bottles without Drain Lines ACCEL Centesis Catheter Other Drainage Collection Devices Utilizing Standard Luer Connections 10

11 ACCEL Centesis Catheter Percutaneous Fluid Drainage Catheter Size Length Needle Gauge High Density Polyethylene Material Resists Kinking, Promotes a Smooth Catheter Insertion Four Large Drainage Holes Spiral around Catheter to Increase Fluid Drainage. Tapered Catheter Tip Provides Excellent Transition for Smooth Catheter Insertion Clear Needle Hub with Luer Lock Connection F 7cm 20g F 10cm 20g F 7cm 19g F 10cm 19g F 15cm 19g 5 Not made with LATEX natural rubber latex DEHP Not made with DEHP Echogenic Needle Ensures Needle Visibility ility during Ultrasound Placement 15cm 10cm 7cm ASEPT 2,000mL Drainage Bag Internal Anti-Reflux Valve ASEPT 2,000mL Drainage Bag ASEPT 2,000mL Drainage Bag Kit with Procedure Pack: One CSR Wrap Containing Three Alcohol Pads, Four Gloves, Six 4 x4 gauze pads, One Foam Catheter Pad, One Self-Adhesive Dressing, One Blue Emergency Slide NOTE: When drainage is performed by patients/caregivers or in a setting outside the hospital where standard dressing change items are not readily available, the ASEPT Drainage Bag Kit must be used. Drain Line LATEX Not made with natural rubber latex Male Luer Lock Connector Fluid Release ease Valve Large 2,000mL Volume Drainage Bag The ASEPT 2,000mL Drainage Bag or Drainage Bag Kit is an accessory to the ASEPT Peritoneal Drainage System and is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only. Universal 600mL Drainage Bag 600mL Universal Drainage Bag with Velcro Strap 20 Long Drainage Tube with Male Luer Lock Adapter LATEX Not made with natural rubber latex Extended Drain Line Male Luer Lock Connector Fluid Release Valve Universal Drainage Bag holds up to 600mL of waste. It has flexible silicone tubing that facilitates trimming to a desired length. The soft Velcro strap cushions securement of bag system to patient. The twist valve facilitates quick and easy disposal of bag contents. The internal anti-reflux valve prevents retrograde contamination. Velcro Strap Internal Anti-Reflux Valve 9

12 Indications for Use - ASEPT Pleural and Peritoneal Drainage System The ASEPT Pleural Drainage System is intended for long-term, intermittent drainage of symptomatic, recurrent pleural effusions. The ASEPT Peritoneal Drainage System is indicated for periodic drainage of recurrent and symptomatic malignant ascites. The primary components are the ASEPT Pleural or Peritoneal Drainage System and the ASEPT Drainage Kits (one 600mL vacuum bottle or one 1,000mL vacuum bottle). Replacement valves and drain lines with 5-in-1 adapters are available as well. Refer to the ASEPT Drainage System Instructions for Use for complete indications, relevant warnings, precautions, complications, and contraindications. These devices have been designed for single use only. Indications for Use - ASEPT Evacuated Drainage Bottle with or without Drain Line The ASEPT 600mL or the ASEPT 1,000mL Evacuated Drainage Bottle is a non-powered, single-patient, portable suction device that consists of a manually operated plastic disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds. This set is used for large wound-areas. (e.g., after surgical operations). Refer to the ASEPT 600mL and 1,000mL Evacuated Drainage Bottle Instructions for Use for relevant warnings, precautions, complications, and contraindications. These devices have been designed for single use only. Indications for Use - ASEPT 2,000mL Drainage Bag The ASEPT 2,000mL Drainage Bag is an accessory to the ASEPT Peritoneal Drainage System and is used for for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea. Refer to the ASEPT 2,000mL Drainage Bag Instructions for Use for relevant warnings, precautions, complications, and contraindications. This device has been designed for single use only. Indications for Use - ASEPT Replacement Valve The ASEPT Replacement Valve is used for replacing the valve attached to the ASEPT Pleural or Peritoneal Drainage Catheter in case of occlusion or malfunction. The ASEPT Pleural or Peritoneal Drainage Catheter is the main component of the ASEPT Pleural or Peritoneal Drainage System. Indications for Use - ASEPT Drainage Line The ASEPT Drainage Line is an accessory to the ASEPT Pleural or Peritoneal Drainage System that is used for connecting the ASEPT Catheter to wall suction or standard fluid collection equipment. The ASEPT Pleural or Peritoneal Drainage Catheter is the main component of the ASEPT Pleural or Peritoneal Drainage System. Indications for Use - ASEPT Evacuated Bare Drainage Bottle The ASEPT 600mL or the ASEPT 1,000mL Evacuated Bare Drainage Bottle is a non-powered, single-patient, portable suction device used to aspirate, remove, or sample body fluids. Refer to the ASEPT 600mL and 1,000mL Evacuated Bare Drainage Bottle Instructions for Use for relevant warnings, precautions, complications, and contraindications. This device has been designed for single use only. Indications for Use - B. Braun Interventional Systems 600mL EVACUATED Drainage Bottle The 600mL Drainage Bottle is a vacuum bottle indicated for use to aspirate, remove, or sample body fluid. Refer to the 600mL Drainage Bottle Instructions for Use for relevant warnings, precautions, complications, and contraindications. This device has been designed for single use only. Indications for Use - ACCEL Centesis Catheter The ACCEL Centesis Catheter is indicated for short-term percutaneous fluid drainage. Refer to the ACCEL Centesis Catheter Instructions for Use for relevant warnings, precautions, complications, and contraindications. This device has been designed for single use only. Indications for Use - Universal Drainage Bag The Closed Fluid Collection System is used for acute and long-term abscess drainage, pleural drainage, and chest drainage. Refer to the Universal Drainage Bag Instructions for Use for relevant warnings, precautions, complications, and contraindications. This device has been designed for single use only. Indications for Use - ACCEL Connection Sets The ACCEL Connection Sets provide a connection between an evacuated container and a patient access catheter for use in short-term percutaneous fluid aspirations and small-volume drainage procedures. Sets are intended for use with a vacuum collection device such as a pre-evacuated container. Refer to the ACCEL Connection Set Instructions for Use for relevant warnings, precautions, complications, and contraindications. This device has been designed for single use only. PRECAUTION: Not intended for use with power injectors. For more information or to place an order, contact your B. Braun Interventional Systems Inc. rep re sen ta tive or call VENA-CAV ( ). Velcro is a Registered Trademark of Velcro Industries Spin-Lock is a Registered Trademark of B. Braun Medical, Inc. Rx only ASEPT is a registered trademark of pfm medical, inc B. Braun Interventional Systems Inc. CV2014 5/15 Manufactured for: B. Braun Interventional Systems Inc. 824 Twelfth Avenue Bethlehem, PA USA Tel: VENA CAV ( ) (USA) Fax:

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