AccessGUDID - DEVICE: OCS Liver System (B00950770)

GUDID

Device Identifier (DI) Information

Brand Name: OCS Liver System
Version or Model: 3440
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3440
Company Name: TRANSMEDICS, INC.

Primary DI Number: B00950770
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084445043 *Terms of Use

Device Description: OCS Liver Bile Salts Set

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:	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?
62877	Donor-organ/tissue/cell preservation solution additive	A powder containing specifically formulated chemicals intended to be dissolved in a donor-organ/tissue/cell preservation solution to supplement the preservative function of the solution; it may have cell, tissue or organ-specific properties to help maintain the viability of donor cells/tissues/organs. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QQK	Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P200031	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
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 4 Inch
Width: 4 Inch
Height: 4 Inch

Device Record Status

Public Device Record Key: 516309b5-477b-4606-9228-8f39310ad007
Public Version Date: December 08, 2022
Public Version Number: 2
DI Record Publish Date: December 01, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B00949381	2	B00950770		In Commercial Distribution	Cardboard Box

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 978-552-0900
Email: xx@xx.xx

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES