Urology Securement Skin Protection Product Catalog

Transcription

1 2017 Product Catalog Urology Securement Skin Protection

2 What We Do Bioderm specializes in the manufacture of innovative male external catheters, skin-friendly securement devices and the accompanying accessories. Our proprietary hydrocolloid and hydrocolloid base of products are hypoallergenic and don t contain natural latex. When applied, it serves as a protective layer preventing irritation and trauma. Bioderm is committed to providing products that offer patients a superior experience centered around comfort, reliability and safety. Our products are cost effective, safer and life enhancing. Compassionate Solutions UROLOGY Men s Liberty and Safe n Dry are revolutionary alternatives to diapers, condom catheters and medically unnecessary Foley catheters. SECUREMENT The CathGrip family of universal catheter securement options provides clinicians with the ability to manage a wide variety of catheters and tubes ranging in size from 2-47 Fr. SKIN PROTECTION Ensure proper product application and removal with the use of BioPlus+ Barrier Prep Wipes and FreeDerm Adhesive Remover.

3 UROLOGY SKU# SKU# Men s Liberty For Outpatient Use Men s Liberty is the innovative alternative to traditional male external catheters. It is completely external and applied just once a day. This discreet, one-size-fits-most option manages men s urinary incontinence in a safe, healthy way. More than 3.5 million units have been used with zero attributable adverse events, including UTIs! Safe n Dry For Acute Care Use Safe n Dry is a male external catheter designed for institutional and hospital use. It is completely external and seals gently and securely to the tip of the penis with BioDerm s proprietary hydrocolloid adhesive XtraDerm. Safe n Dry is currently private labeled in the US for Eloquest Healthcare as ReliaFit. How Does It Work? Men s Liberty & Safe n Dry are made from hydrocolloid, a medical adhesive that creates a secure, skin friendly seal around the urinary opening. The Men s Liberty is designed for use in the out-patient setting and includes an integral collection chamber that holds up to 8 fl. oz (250mL). When the urge hits, users can fill the collection chamber, which can then be discreetly emptied whenever they get the opportunity into a toilet through the stop valve located on the bottom of the product. It couldn t be easier! Features Has a completely external design Fits most male anatomy Keeps men dry and comfortable Average wear time of hours 8oz urine collection pouch can be emptied easily throughout the day Replaces diapers, condom catheters and medically unnecessary Foley catheters BioDerm Product Catalog 1

4 UROLOGY Kind Klamp The Kind Klamp is designed to temporarily stop the flow of urine through the urethra when applying the Men s Liberty. This simple male incontinence product helps men who are dribbling or leaking and are having trouble applying the Men s Liberty and Safe n Dry devices. Features Made from durable engineered plastic and ultra soft foam for added comfort Designed to fit small, medium and large anatomy No wires or metal ensures that the BioDerm Penile Clamp is skin friendly and can be washed without the potential of rust or corrosion Easy use clasp can be closed and released with one hand! Curved upper arm for improved comfort Long lasting hinge designed for multiple cycles SKU# Bed and Leg Bags Features Connects to Men s Liberty Kink-resistant tubing Convenient drain spout Anti-reflux valve All fluid pathways are sterile Leg bag straps included 1000 ML LEG BAG SKU# ML BED BAG SKU# BioDerm Product Catalog

5 SECUREMENT The CathGrip Family The CathGrip family of universal catheter securement options provides clinicians with the ability to manage a wide variety of catheters and tubes ranging in size from 2-47 Fr. Each product is based on BioDerm s proprietary hydrocolloid with features that solve a wide variety of challenges. When properly applied, these devices provide a comfortable fit and secure hold for up to seven days. The soft straps with no-slip grips are durable for repeat positioning, perfect for continual ease of use. CathGrip is the new standard of care chosen by clinical teams and purchasing departments. UniGrip UniGrip is a truly universal system that securely holds tubes from 2-47 Fr. Available in single or double straps, UniGrip provides all over securement with a skin-friendly hydrocolloid adhesive to prevent skin injuries. Soft straps with no-slip grips are durable for repeat positioning. Sterile and non-sterile available. Features Available in single or dual straps in the large size Hydrocolloid adhesive oval Hypoallergenic & latex-free Soft straps with no-slip grip Simple repeat positioning Medium SKU# Jackson Pratt Drains Nephrostomy Drain Suprapubic Urinary Catheter Ventricular Assist Device (VAD) Chest Tube PEG Tube J Tube Urinary Catheter Drainage Device Large SKU# Small SKU# Uses listed above are not all inclusive. May vary based on tube location, infection prevention protocols and presence of exudating wounds. Large (1 Strap) SKU# BioDerm Product Catalog 3

6 SECUREMENT Diana L. Gallagher MS, RN, CWOCN, CFCN Diana L. Gallagher is a certified wound, ostomy and continence nurse and educator. I love the versatility of the CathGrip line of products. These amazing securement devices allow me to easily position even the most difficult of drains, secure them into place and not have any concerns. Because CathGrip products are made of hydrocolloid and have no hard surfaces, I don t have to worry about pressure injuries or skin damage. I highly recommend them. PEG Protect Designed specifically for use with PEG tubes, PEG Protect brings our skin friendly hydrocolloid securement to long and short term PEG patients. PEGProtectTM Features Secures both standard and low profile PEG tubes with ease Allows for regular tube rotation for traditional and low profile PEG tubes Reduces the risk of dislodgement and tube migration Provides a skin friendly hydrocolloid barrier against bodily fluid, bruising and excoriation Reduces potential for tube kinking Two piece design allows for variable securement location related to the PEG tube insertion site SKU# SlipGrip Designed specifically for use in Interventional Radiology, SlipGrip can help standardize securement and increase patient comfort with skin friendly hydrocolloid. With a wear time up to seven days, SlipGrip is an excellent choice for inpatient and outpatient tube securement. Chest Tubes Biliary Drain Nephrostomy Dialysis SKU# BioDerm Product Catalog

7 SECUREMENT HoldMe Designed to prevent pressure injuries and skin tearing with low-profile proprietary hydrocolloid securement, especially important when dealing with tender skin. Low profile oval pairs that are sized for difficult to apply areas. Will hold securely for up to 7 days. Available as sterile or non-sterile. Ventriculostomy NG/OG Tube Skin Protection Peritoneal Dialysis Catheter Nephrostomy Epidural Catheter SIZE SKU# X-Large Large Medium Small X-Small Grip & Seal Grip & Seal extends the security of our hydrocolloid base to support insertion site securement. Hydrocolloid wings form an occlusive seal that securely holds any tube from 2-47 Fr. and can help reduce dislodgement and minimize the risk of infection. Only available as sterile. NG/OG Tube Chest Tube Suprapubic Epidural Dialysis SIZE SKU# Large Medium Small WingSeal Designed specifically for use with epidural and nephrostomy tubes, the WingSeal can help standardize your epidural practice and increase patient comfort with skin friendly, low profile hydrocolloid securement. Only available as sterile. Epidural SKU# Nephrostomy BioDerm Product Catalog 5

8 SKIN PROTECTION BioPlus+Barrier Prep Wipe BioPlus+ improves hydrocolloid adhesion by up to 50%. A BioPlus+ wipe is included in most BioDerm products and is also available as a stand alone product. SKU# FreeDerm Adhesive Remover Instantly removes hydrocolloid without irritation and evaporates rapidly with no residue. Allows immediate re-application of an adhesive device without washing. Available as 1oz (30mL), 3oz (90mL) pump spray or single use ampoules (1mL). Features Safe and gentle for all patients No-sting Instantly removes hydrocolloid Flash dries in less than 15 seconds Reduces skin trauma from tape and dressing removal including infection risk, inflammatory damage and edema No harsh chemicals Oil and lotion free SIZE SKU# 1oz Spray Bottle oz Spray Bottle Ampoules, Box of BioDerm Product Catalog

9 Now That You Know Our Products BioDerm provides compassionate solutions for customers around the world. Safer, easy to use and cost effective, our innovative hydrocolloid technology is the next evolution in patient care. Be a part of the future of healthcare technology today! OUTPATIENT BioDerm s products are sold through our world-class customer service center, based in Largo, Florida. Our friendly customer service representatives are trained to understand the conditions associated with urinary incontinence and are extremely knowledgeable about all of BioDerm s products. BioDerm also provides on-site clinical support and a robust quality auditing program to ensure the highest quality service and support. ACUTE CARE BioDerm s CathGrip product line is sold through a growing network of specialty distributor and independent representatives targeting acute care, long-term care and other surgical centers. The CathGrip line of products is transforming care in critical care units, interventional radiology, medical/ surgical units, wound care clinics and more with solutions that help reduce the incidence of medical device related pressure injuries and catheters becoming dislodged. BioDerm s urinary management products for acute care are currently sold through BioDerm as Safe n Dry outside the United States and by Eloquest Healthcare as ReliaFit and the ReliaFit Kit with CathGrip inside the United States. INTERNATIONAL BioDerm s products are currently available for sale in the United Kingdom, Canada, the Netherlands, South Korea, Poland and the United Arab Emirates through a network of independent distribution partners in each country. PARTNERSHIPS BioDerm s urinary management products for acute care are currently private labeled and sold by Eloquest Healthcare as ReliaFit and the ReliaFit Kit with CathGrip. Other BioDerm products are available for private label collaboration for target markets and partnerships. BioDerm Product Catalog 7

10 ADDITIONAL INFORMATION Regulatory Information BioDerm is registered with the US Food and Drug Administration and other international regulatory bodies. Copies of all registration documents are available upon request or online at Product Category Accessories, catheter CathGrip Bandage, liquid BioPlus+ Sterile Bandage, liquid, skin protectant BioPlus+ Skin Wipe Device, intravascular catheter securement Grip&Seal Catheter Securement Device; Grip&Seal Catheter Securement Device Sterile; Hold Me Catheter Securement Device; PEGprotect; UniGrip Catheter Securement Device; WingSeal Bag, urine collection, leg, for external use, sterile BioDerm 2,000mL Bag with Urimeter; BioDerm Urine Collection Bag 1,000mL Sterile Fluid Pathway ; BioDerm Urine Collection Bag 2,000mL Sterile Fluid Pathway Solvent, adhesive tape FreeDerm Adhesive Remover Device, paste-on for incontinence, non-sterile - BioDerm ECD and XLS; LIBERTY LP AND LS WITH INTEGRAL URINE COLLECTION CHAMBER; Liberty Safe and Dry LP and LS; ReliaFit Male Urinary Device; ReliaFit Male Urinary Device with CathGrip; Safe and Dry LP and LS Connector, catheter Extension Tube Clamp, penile - BioDerm Penis Clamp Accessories, catheter CathGrip Role Manufacturer Specification Developer Specification Developer Manufacturer Specification Developer Specification Developer Contract Manufacturer; Manufacturer Specification Developer Specification Developer Manufacturer US Food and Drug Administration Establishment Registration Number: BioDerm, Inc., rd Court North, Largo, FL Status: Active Authorized Representative: Europe CE Registration #: CA Advena Ltd Pure Offices, Plato Close, Warwick CV34 6WE UK British Standards Institute Certificate of Registration: Quality Management System ISO-13485:2003 Certificate #: FM Originally Registered: 07/06/2011 Expiration Date: 07/05/2017 To Order For US orders Please send a completed purchase order to CustomerCare@BioDermInc.com or fax to (888) For International orders Please send a completed purchase order to CustomerCare@BioDermInc.com. If this is your first order, be sure to include a completed International Order form including all relevant shipping information. Minimum order quantity is one box of a single SKU. Shipments will not be sent until payment has been received. Depending on the type and speed of shipment you have chosen, please be aware that it may take several weeks for your shipment to arrive. If you require a Pro Forma Invoice in order to complete your wire transfer, please contact CustomerCare@BioDermInc.com. 8 BioDerm Product Catalog

11 ADDITIONAL INFORMATION Product Summary Product Name HCPCS Code Catalog/SKU Number* Size Units Per Box Boxes Per Case Expiration Date (from the date of manufacture)* UROLOGY Men s Liberty A One Size months** Safe n Dry NA One Size months** Kind Klamp A One Size months Drainage Bag Leg A mL months Drainage Bag Bedside A mL months SECUREMENT CathGrip UniGrip UniGrip Large x months** UniGrip Large (Non-Sterile) 51300NS 4 x months** UniGrip Large (1 Strap) x months** UniGrip Large (1 Strap, Non-Sterile) A4333 for 51350NS 4 x months** UniGrip Medium Urinary x months** UniGrip Medium (Non-Sterile) 51301NS 3 x months** UniGrip Small x months** UniGrip Small (Non-Sterile) 51250NS 3 x months** CathGrip Grip & Seal Grip & Seal Large x months** Grip & Seal Medium x months** Grip & Seal Small A5200 for x months** PEG Protect Percutaneous x months** SlipGrip x months** WingSeal x months** CathGrip HoldMe HoldMe X-Large x months** HoldMe Large Varies Based on x months** HoldMe Medium Type of Tubing x months** HoldMe Small Secured x months** HoldMe X-Small x months** SKIN PROTECTION BioPlus+ Wipe A One Size months FreeDerm Spray (1oz) A oz months FreeDerm Spray (3oz) A oz months FreeDerm Ampoule A mL months Note: Add suffix NS to UniGrip or HoldMe to order non-sterile product. *Expiration date is based on the earliest expiration date of the components. Products are not shipped within one year of expiration. **Expiration date indicates the expiration of the included BioPlus+ wipe. Product Availability Product availability is dependent on the regulations of your country. Not all products are available in all countries. BioDerm Product Catalog 9

12 BioDerm, Inc rd Court North, Largo, FL US Orders: International Orders: Support: Web: BioDermInc.com BioDermInc.com BioDermInc 2016 BioDerm, Inc. All rights reserved. BioDerm, CathGrip and Safe n Dry are registered trademarks of BioDerm, Inc. BioPlus+, FreeDerm, KindKlamp, Grip&Seal, HoldMe, PEG Protect, SlipGrip, UniGrip WingSeal and Men s Liberty are trademarks of BioDerm, Inc. All other trademarks acknowledged. U.S. patents #7,896,857, #8,551,062, #D767,761. CathGrip U.S. patent pending. LT B