DEVICE: LUNGguard (00850005470151)

Device Identifier (DI) Information

LUNGguard
PRGNX-5005-001
In Commercial Distribution

Paragonix Technologies Inc
00850005470151
GS1

1
961780660 *Terms of Use
Paragonix LUNGguard Shipper Base
CLOSE

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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KDN System, Perfusion, Kidney
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

cd1e3a98-2f50-4f42-a493-fb93343a05d2
July 30, 2024
2
December 13, 2022
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE