AccessGUDID - DEVICE: Servator H (00851983008060)

GUDID

Device Identifier (DI) Information

Brand Name: Servator H
Version or Model: GTS-SERV-HTK-5000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GLOBAL TRANSPLANT SOLUTIONS, INC.

Primary DI Number: 00851983008060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021248196 *Terms of Use

Device Description: Servator H Solution is intended for flushing and cold storage of abdominal organs at the time of removal from the donor in preparation fort storage, transportation, and the eventual transplantation into a recipient.

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):	No
Over the Counter (OTC):	No
Kit:	No
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?
48039	Kidney donor-organ preservation/transport perfusion set	A collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated kidney(s) during its preservation, evaluation, and transport in a kidney donor-organ preservation/transport system from the donor to the receiver hospital where the organ will be transplanted into the recipient. It typically includes a blood/fluid perfusion circuit, reservoir, pump, oxygenator, warmer, a urine collection reservoir, flow/pressure sensors, access and control valves, cannulae/connectors/tools to connect the appropriate vessels of the kidney and tubing lines, filters and bags to add/remove blood and solutions. This is a single-use device.	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: 23cf87e6-e291-4ba3-ac86-33c14a011d76
Public Version Date: April 29, 2020
Public Version Number: 1
DI Record Publish Date: April 21, 2020