DEVICE: LUNGguard (00850005470151)
Device Identifier (DI) Information
LUNGguard
PRGNX-5005-001
In Commercial Distribution
Paragonix Technologies Inc
PRGNX-5005-001
In Commercial Distribution
Paragonix Technologies Inc
Paragonix LUNGguard Shipper Base
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
16461 | General-purpose donor-organ preservation/transport system |
A non-dedicated system designed to support and maintain any donated organ (e.g., heart, kidney, liver) during transport from the donor to the receiving hospital where the organ will be transplanted into the recipient. This system will provide technical support functions to keep the organ in as near-physiologic state as possible.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KDN | System, Perfusion, Kidney |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cd1e3a98-2f50-4f42-a493-fb93343a05d2
July 30, 2024
2
December 13, 2022
July 30, 2024
2
December 13, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00850005470144 | 1 | 00850005470151 | In Commercial Distribution | Inner Box | |
20850005470148 | 1 | 00850005470144 | In Commercial Distribution | Outer Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined