DEVICE: RELiZORB (00862205000212)

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Device Identifier (DI) Information

RELiZORB
200209 / 200211

ALCRESTA PHARMACEUTICALS, INC
00862205000212
GS1
1
Enzyme Packed Cartridge with ENFit.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN 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.
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FDA Product Code

[?]
Product Code Product Code Name
PLQ Enzyme Packed Cartridge
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 27 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00862205000229 10 00862205000212 In Commercial Distribution Box
00862205000243 30 00862205000212 In Commercial Distribution Box
00862205000236 10 00862205000212 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
6177149946
rwagner@alcresta.com
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