Home GUDID 38032979792290 CARPEDIEM
Primary DI 38032979792290
Brand CARPEDIEM
Company BELLCO SRL
Model IB0595580
Device description BL 250 HEMOFILTRATION/HEMODIALYSIS KIT 025 FOR CARPEDIEM
Published 2020-06-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name QIR Pediatric Hemodialysis System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QIR Pediatric Hemodialysis System Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 38032979792290 Package GS1 4 In Commercial Distribution 08032979792299 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 38032979792290 38032979792290 08032979792299 08032979792299 8032979792299
GMDN Terms# Term, Definition table Term Definition Haemodialysis/haemofiltration system component set A collection of sterile devices, which includes a dialyser, intended to be integrated within a system for haemodialysis and haemofiltration to treat acute or chronic renal failure by removing toxins and/or replacing electrolytes in blood; it may also be used in the treatment of fluid overload (hypervolemia). In addition to the dialyser the set includes an array of tubing and connectors, and is intended to be connected to the system pump/monitor; it is intended to be used in the home and healthcare settings. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 avoid direct sunlight Special Storage Condition, Specify 0 0 avoid direct sunlight; Special Storage Condition, Specify 0 0 avoid direct sunlight Storage Environment Temperature 5 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 338685723 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false 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# 
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