Ingredients Original Aqua, carrageenan, maltodextrin, potassium sorbate, sucrose, calcium chloride, citric acid, color, aroma.
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1 General Information Description Gloup is a universal gel that eases the intake of solid, oral medication. Gloup is universal as it does not interact with medication and it is suitable for everyone who can swallow autonomously, from the age of two years. The intake of solid medication, such as tablets, pills and capsules, is often perceived as difficult. Studies show that roughly 40% of the population suffer from medication intake problems (M.I.P.). M.I.P. occur in every age group and predominantly in elderly and children. M.I.P. are not necessarily linked to a disease or an illness. Gloup is a Class I Medical Device. Ingredients Original Aqua, carrageenan, maltodextrin, potassium sorbate, sucrose, calcium chloride, citric acid, color, aroma. All ingredients are of natural origin Sugar Free Aqua, carrageenan, maltodextrin, potassium sorbate, aspartame, calcium chloride, citric acid, (natural) color, (natural) aroma Shelf life & Storage conditions 24 months after production, 2 months after opening Keep stored between 2ºC and 25ºC at all times Intrastat Code Transportation Product should be transported by temperature controlled means between 2ºC and 25ºC. Prolonged exposure to higher temperatures will cause a significant loss of colour. Classification: EC Medical Device, Class I according to MDD 2007/47 and 93/42. Certificate number NL-CA (Sugar Free) NL-CA (Original) USA Medical Device, 510(k) Exempted GMDN Code Scope of application EC 1336/2008 EC 1907/2006 Oral lubrification jelly to facilitate the intake of solid medication Not classified Raw materials are exempted or (pre-) registered ISO Certification Production: Product is produced in the EC in accordance with the stipulations of: ISO 13485:2003 ISO 9001:2008 Page 1
2 Product release specifications (Original & Sugar Free) ph (as it 5,0 +/- 1,0 Aspect & Colour Clear to slightly hazy pink liquid Viscosity / Density 20ºC) 1,01 +/- 0,2 Microbiological Analysis TYMC TAMC Staphylococcus Aureus Pseudomonas Aeruginosa < 10 kve/g < 10 kve/g Certificate of Analysis Certificate of analysis is available on every batch upon request Product Characteristics Heavy metals (ppm) Arsenic Cadmium Mercury Lead Chromium Nickel < 1.0 Preservative Potassium Sorbate Anti-oxidant Pesticide Origin of starting materials Vegetable BSE / TSE status Due to the vegetable origin of the starting materials, no BSE/TSE proteins to be expected GMO status Non GMO Alcohol CMR Classified Ingredients Kosher Certification Halal Certification Not Present Not available Not available Page 2
3 Nutritional information Energy (kcal/100 g) Original Sugar Free 7 12 Carbonhydrates (g/100 g) Whereas present as sugar Original 12 < 11 Fat (g/100 g) 0 Sugar Free 2 < 0.02 Fibers (g/100 g) < 0.02 Allergenes according to EC 2003/89 (Original & Sugar Free) Gluten Wheat Rye Barley Oats Spelt Kamut Nuts Almonds Hazelnuts Cashew Pecan Nuts Brazil Nuts Pistachio Nuts Macadamia nuts Crustaceans Egg Fish Peanuts Soy Cow s milk Celery Molluscs Musterd Lactose Sesame Cocoa Sulpher Glutamate Lupin Coriander Chicken meat Corn/Maize Legumes Beef Carrot Pork Page 3
4 Package Form, Weight and Sizes Original Sugar Free Sachet 75 ml 150 ml 500 ml Sachet 75 ml 150 ml 500 ml Unit Form Presentation Sachet Tube in Tube in Flask Sachet Tube in Tube in Flask Nett content (ml) Primary package and weight (grams) Sachet Tube 89 ± 1 Tube 175 ± 1 Flask REF number EAN Number (see page 5) Size & Weight unit form (cm & grams) 8 x x 4.6 x ± 1 Userinformation On Sachet On unit Extended Q&A / Informationleaflet Packed in-, Size - & Weight Box (number, cm, kilograms) Packed in-, Size - & Weight Carton (number, cm, kilograms) Online Packed in unit 500 sachet 30 x 22 x units 2.8 n.a. 4 es 12 Pallet (number, cm, kilograms) Note: please specify the required pallet size and material on your orders CP1 Material Pallet: Plastic Euro Material Pallet: Plastic or Wood (non IPPC certified) n.a. 505 n.a x 5.6 x ± 1 On unit Packed in unit 15 units es Ø7.5 x 15.5 Sachet Tube 89 ± 1 Tube 175 ± 1 Flask EAN Number (see page 5) 12 x x 4.6 x ± 1 On label On Sachet On unit Online Online Packed in unit 6 units 3.6 Dispensers packed per unit 4 es x 120 x x 120 x sachet 30 x 22 x units 2.8 n.a. 4 es 12 n.a. 505 n.a x 5.6 x ± 1 On unit Packed in unit 15 units es Ø7.5 x 15.5 On label Online 6 units 3.6 Dispensers packed per unit 4 es Page 4
5 Productcodes Gloup Order Code Language Description Taste Bar/EAN code G-008-SF-B Gloup Sugar free Sachet 8 ml Not applicable G-005-OR-B Gloup Original Sachet 5 ml Strawberry/Banana Not applicable G B-0004 NL/EN/FR/DE Gloup Sugar free Tube 75 ml G B-0004 NL/EN/FR/DE Gloup Sugar free Tube 150 ml G B-0004 NL/EN/FR/DE Gloup Sugar free Bottle/ Dispenser 500 ml G B-0502 NL/EN/FR/DE Gloup Original Tube 75 ml Strawberry/Banana G B-0502 NL/EN/FR/DE Gloup Original Tube 150 ml Strawberry/Banana G B-0502 NL/EN/FR/DE Gloup Original Bottle/ Dispenser 500 ml Strawberry/Banana G B-0004 FI/SE/NO/DK Gloup Sugar free Tube 75 ml G B-0004 FI/SE/NO/DK Gloup Sugar free Tube 150 ml G B-0004 FI/SE/NO/DK Gloup Sugar free Bottle/ Dispenser 500 ml G B-0502 FI/SE/NO/DK Gloup Original Tube 75 ml Strawberry/Banana G B-0502 FI/SE/NO/DK Gloup Original Tube 150 ml Strawberry/Banana G B-0502 FI/SE/NO/DK Gloup Original Bottle/ Dispenser 500 ml Strawberry/Banana G B-0004 FR/EN/AR Gloup Sugar free Tube 75 ml G B-0004 FR/EN/AR Gloup Sugar free Tube 150 ml G B-0004 FR/EN/AR Gloup Sugar free Bottle/ Dispenser 500 ml G B-0502 FR/EN/AR Gloup Original Tube 75 ml Strawberry/Banana G B-0502 FR/EN/AR Gloup Original Tube 150 ml Strawberry/Banana G B-0502 FR/EN/AR Gloup Original Bottle/ Dispenser 500 ml Strawberry/Banana G B-0004 NZA Gloup Sugar free Tube 75 ml G B-0004 NZA Gloup Sugar free Tube 150 ml G B-0004 NZA Gloup Sugar free Bottle/ Dispenser 500 ml G B-0501 NZA Gloup Original Tube 75 ml Orange G B-0501 NZA Gloup Original Tube 150 ml Orange G B-0501 NZA Gloup Original Bottle/ Dispenser 500 ml Orange G B-0004 EN/ES/IT/PT Gloup Sugar free Tube 75 ml G B-0004 EN/ES/IT/PT Gloup Sugar free Tube 150 ml G B-0004 EN/ES/IT/PT Gloup Sugar free Bottle/ Dispenser 500 ml G B-0502 EN/ES/IT/PT Gloup Original Tube 75 ml Strawberry/Banana G B-0502 EN/ES/IT/PT Gloup Original Tube 150 ml Strawberry/Banana G B-0502 EN/ES/IT/PT Gloup Original Bottle/ Dispenser 500 ml Strawberry/Banana G B-0004 DE/RO/HU/SVK Gloup Sugar free Tube 75 ml G B-0004 DE/RO/HU/SVK Gloup Sugar free Tube 150 ml G B-0004 DE/RO/HU/SVK Gloup Sugar free Bottle/ Dispenser 500 ml G B-0502 DE/RO/HU/SVK Gloup Original Tube 75 ml Strawberry/Banana G B-0502 DE/RO/HU/SVK Gloup Original Tube 150 ml Strawberry/Banana G B-0502 DE/RO/HU/SVK Gloup Original Bottle/ Dispenser 500 ml Strawberry/Banana G B-0004 DE/CZE/KR/BU Gloup Sugar free Tube 75 ml G B-0004 DE/CZE/KR/BU Gloup Sugar free Tube 150 ml G B-0004 DE/CZE/KR/BU Gloup Sugar free Bottle/ Dispenser 500 ml G B-0502 DE/CZE/KR/BU Gloup Original Tube 75 ml Strawberry/Banana G B-0502 DE/CZE/KR/BU Gloup Original Tube 150 ml Strawberry/Banana G B-0502 DE/CZE/KR/BU Gloup Original Bottle/ Dispenser 500 ml Strawberry/Banana G B-0004 DE/SRB/SVN/PL Gloup Sugar free Tube 75 ml G B-0004 DE/SRB/SVN/PL Gloup Sugar free Tube 150 ml G B-0004 DE/SRB/SVN/PL Gloup Sugar free Bottle/ Dispenser 500 ml G B-0502 DE/SRB/SVN/PL Gloup Original Tube 75 ml Strawberry/Banana G B-0502 DE/SRB/SVN/PL Gloup Original Tube 150 ml Strawberry/Banana G B-0502 DE/SRB/SVN/PL Gloup Original Bottle/ Dispenser 500 ml Strawberry/Banana Under development Page 5
6 Company information Rushwood Name of the Company Rushwood b.v. Postal address Ottergeerde VM Raamsdonksveer The Netherlands Warehouse address Opening hours Warehouse Release numbers Telephone Fax Ottergeerde VM Raamsdonksveer The Netherlands Monday to Thursday: 08:30 12:00 13:00 16:00 Friday: 08:30 12:00 VO number of order confirmation +31 (0) (0) VAT Number Chambre of Commerce NL B01 Breda Chambre of Commerce Number Bank details Swift/BIC code bank ABN Amro Bank Arendsplein KX Oosterhout ABNANL2A Conventional Number IBAN Number NL32ABNA Page 6
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