Home GUDID 20862205000230 RELiZORB
Primary DI 20862205000230
Brand RELiZORB
Company Alcresta Therapeutics, Inc.
Model 100300/100301
Device description Ezyme Packed Cartridge with ENFit
Published 2024-05-08
Public version status New
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 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 20862205000230 Package GS1 10 In Commercial Distribution 20862205000254 Package GS1 30 In Commercial Distribution 00862205000250 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 20862205000230 20862205000230 20862205000254 20862205000254 00862205000250 00862205000250 862205000250 0862205000250
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 DM exempt false Premarket exempt false HCT/P false Kit false 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00862205000250 RELiZORB Alcresta Therapeutics, Inc. PLQ 2024-05-08 00862205000205 Relizorb Alcresta Therapeutics, Inc. PLQ 2016-09-23 00862205000212 RELiZORB Alcresta Therapeutics, Inc. PLQ 2016-09-23
alcresta.com