AccessGUDID - DEVICE: Organ Care System (B00972500)

GUDID

Device Identifier (DI) Information

Brand Name: Organ Care System
Version or Model: 1411
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1411
Company Name: TRANSMEDICS, INC.

Primary DI Number: B00972500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084445043 *Terms of Use

Device Description: OCS Mobile Base

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":	Yes
For Single-Use:	No
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?
66882	Surgical/procedural instrument trolley	An open mobile cart intended to store and/or transport instruments for use during surgical and/or medical procedures within a hospital/institution department (e.g., transport between operating and central sterilization rooms). It is typically in the form of a table on wheels with an open shelf/platform underneath and may be used as a surface on which to place instruments in a hygienic manner during procedures. It does not include doors (i.e., not a cabinet). It is not intended to be used to perform procedures or for sterilization of instruments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QBA	Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
QIK	Organ Care System (Ocs) Heart System
QQK	Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

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: No
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 -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 21 Inch
Width: 28 Inch
Height: 10 Inch

Device Record Status

Public Device Record Key: e5798858-62ca-4a3e-b569-598a8d14ca58
Public Version Date: September 18, 2026
Public Version Number: 1
DI Record Publish Date: September 10, 2026

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B00972503	1	B00972500		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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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