AccessGUDID - DEVICE: Belzer MPS (UW Machine Perfusion Solution ) (00810805000095)

GUDID

Device Identifier (DI) Information

Brand Name: Belzer MPS (UW Machine Perfusion Solution )
Version or Model: MPS-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRESERVATION SOLUTIONS INC

Primary DI Number: 00810805000095
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 090266979 *Terms of Use

Device Description: Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL

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?
18004	Donor-organ/tissue/cell preservation solution	A solution intended to be used for the flushing, transport, storage and preservation of donor cells, tissues and/or organs (e.g., stem cells, skin, amniotic membrane, cardiovascular tissue, bone, tendon, kidney, liver, heart, pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain cell/tissue/organ viability until implantation in the recipient; some types may be combined with blood. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDN	System, Perfusion, Kidney

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080432	000

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
Total Volume: 1000 Milliliter

Device Record Status

Public Device Record Key: d4ab21f5-8561-489d-8192-aaef9cf35ab2
Public Version Date: December 08, 2022
Public Version Number: 4
DI Record Publish Date: October 22, 2016