Home GUDID 00862205000205 Relizorb
Primary DI 00862205000205
Brand Relizorb
Company Alcresta Therapeutics, Inc.
Model 100103
Device description Enzyme Packed Cartridge
Published 2016-09-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name PLQ Enzyme Packed Cartridge
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PLQ Enzyme Packed Cartridge Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10862205000202 Package GS1 30 In Commercial Distribution 20862205000209 Package GS1 12 In Commercial Distribution 30862205000206 Package GS1 10 In Commercial Distribution 40862205000203 Package GS1 24 In Commercial Distribution 50862205000200 Package GS1 10 In Commercial Distribution 60862205000207 Package GS1 24 In Commercial Distribution 00862205000205 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10862205000202 10862205000202 20862205000209 20862205000209 30862205000206 30862205000206 40862205000203 40862205000203 50862205000200 50862205000200 60862205000207 60862205000207 00862205000205 00862205000205 862205000205 0862205000205
GMDN Terms# Term, Definition table Term Definition Enteral feed fat-digestion cartridge A non-sterile, noninvasive device intended to be connected to an enteral feeding tube to digest (i.e., hydrolyse) the fat content in an enteral feeding solution as it passes through the device, typically used for patients unable to produce pancreatic fat digestive enzymes. It is a small plastic housing with connectors that contains a porous filter and the enzyme lipase. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 27 Degrees Celsius
Regulatory Flags# DUNS number 078683247 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00862205000250 RELiZORB Alcresta Therapeutics, Inc. PLQ 2024-05-08 20862205000230 RELiZORB Alcresta Therapeutics, Inc. PLQ 2024-05-08 00862205000212 RELiZORB Alcresta Therapeutics, Inc. PLQ 2016-09-23
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