Home GUDID 37332414121595 NA - NA
Primary DI 37332414121595
Brand NA - NA
Company GAMBRO DASCO SPA
Model 115959
Catalog number 115959
Device description Accessory Drain Bag (5L); Accessory for hemodialysis
Published 2025-01-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile true
Single use true Product Codes# Code, Name table Code Name MON SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MON System, Hemodialysis, Remote Accessories Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 37332414121595 Package GS1 40 In Commercial Distribution 07332414121594 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 37332414121595 37332414121595 07332414121594 07332414121594 7332414121594
GMDN Terms# Term, Definition table Term Definition Extracorporeal circuit waste bag A flexible container intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., autotransfusion, haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and rinsing of ultrafiltrate fluid which may contain blood components. The device typically consists of a plastic pouch with a piece of short tubing and a connector (e.g., Luer-lock) intended to be connected to the tubing system of the extracorporeal circuit and possibly an outlet tap. The contents are considered potentially contaminated and should be disposed of according to local requirements. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 5 Liter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 The accessories for hemodialysis must be stored in a dry place, between 0°C (32°F) and 30°C (86°F)
Regulatory Flags# DUNS number 428788780 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07332414118914 AUTO EFFLUENT SET GAMBRO UF SOLUTIONS, INC MON 2025-08-18 57332414118919 AUTO EFFLUENT SET GAMBRO UF SOLUTIONS, INC MON 2025-08-18 07332414121594 NA - NA GAMBRO DASCO SPA MON 2025-01-30 05060497260078 Home Water Cart QUANTA DIALYSIS TECHNOLOGIES LIMITED MON 2023-01-05 B144MPC14171 Molded Products, Inc. MOLDED PRODUCTS, INC. MON 2022-10-04 B144MPC14152 Molded Products, Inc. MOLDED PRODUCTS, INC. MON 2022-08-03 B144MPC14202 Molded Products, Inc. MOLDED PRODUCTS, INC. MON 2022-08-03 05060497260061 Clinic Water Cart QUANTA DIALYSIS TECHNOLOGIES LIMITED MON 2021-09-27 07332414075828 NA GAMBRO DASCO SPA MON 2021-07-30 37332414075829 NA GAMBRO DASCO SPA MON 2021-07-30 00858293006885 Spiral Coil Tubing, Clear REPROCESSING PRODUCTS CORPORATION MON 2021-05-17 00858293006892 Spiral Coil Tubing, Trans Red REPROCESSING PRODUCTS CORPORATION MON 2021-05-17 00858293006908 Spiral Coil Tubing, Trans Blue REPROCESSING PRODUCTS CORPORATION MON 2021-05-17 00858293006861 Sani-lok Blood Port Barrier Adaptor REPROCESSING PRODUCTS CORPORATION MON 2021-05-13 00858293006878 Sani-lok Blood Port Barrier Adaptor REPROCESSING PRODUCTS CORPORATION MON 2021-05-13 00858293006847 E-Z Draw Sample Port REPROCESSING PRODUCTS CORPORATION MON 2021-04-06 00858293006359 E-Z Draw REPROCESSING PRODUCTS CORPORATION MON 2020-10-13 00858293006830 E-Z Draw REPROCESSING PRODUCTS CORPORATION MON 2020-10-13 04046955348923 Streamline Dialyzer Holder B. BRAUN MEDICAL INC. MON 2020-08-07 04046955348916 Streamline Dialyzer Holder B. BRAUN MEDICAL INC. MON 2020-08-07 B144MPC1400B2 Molded Products, Inc. MOLDED PRODUCTS, INC. MON 2019-09-04 B144MPC14052 Molded Products, Inc. MOLDED PRODUCTS, INC. MON 2019-09-04 B144MPC7901 Molded Products, Inc. MOLDED PRODUCTS, INC. MON 2019-09-04 00858293006458 Luer Fitting Female REPROCESSING PRODUCTS CORPORATION MON 2019-08-30 00858293006465 Luer Fitting Male REPROCESSING PRODUCTS CORPORATION MON 2019-08-30 00858293006755 Pump Spring, Weak REPROCESSING PRODUCTS CORPORATION MON 2019-08-30 00858293006762 Pump Spring, Strong REPROCESSING PRODUCTS CORPORATION MON 2019-08-30 10858293006455 Luer Fitting Female REPROCESSING PRODUCTS CORPORATION MON 2019-08-30 10858293006462 Luer Fitting Male REPROCESSING PRODUCTS CORPORATION MON 2019-08-30 00858293006472 Guage REPROCESSING PRODUCTS CORPORATION MON 2019-08-30
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