AccessGUDID - DEVICE: Paragonix SherpaPak Cardiac Transport System (00869582000347)

GUDID

Device Identifier (DI) Information

Brand Name: Paragonix SherpaPak Cardiac Transport System
Version or Model: SHRP-1001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Paragonix Technologies Inc

Primary DI Number: 00869582000347
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961780660 *Terms of Use

Device Description: Paragonix SherpaPak Cardiac Transport System Canister Ships with 4 heart connectors: 00869582000354 (10mm x 1) 00869582000361 (18mm x 1) 00869582000378 (25.4mm x 1) 00869582000385 (32mm x 1)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
MSB	System And Accessories, Isolated Heart, Transport And Preservation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4703ae4f-3944-4685-8a01-9fb4bbac5680
Public Version Date: July 30, 2024
Public Version Number: 2
DI Record Publish Date: February 15, 2019