AccessGUDID - DEVICE: OCS Heart System (B00913600)

GUDID

Device Identifier (DI) Information

Brand Name: OCS Heart System
Version or Model: 1406
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1406
Company Name: TRANSMEDICS, INC.

Primary DI Number: B00913600
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084445043 *Terms of Use

Device Description: OCS Heart Gas Cylinder

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:	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?
62834	Donor-organ preservation/transport system gas refillable cylinder	A portable container designed as a refillable cylinder to hold a custom gas mixture for use in a donor-organ (e.g., kidney, lung, liver, heart) preservation/transport system. It is typically made of aluminium and fibre glass; the contained gas is typically a custom mix of oxygen, carbon dioxide, and nitrogen used for preservation and/or evaluation of the extracorporeal organ. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QIK	Organ Care System (Ocs) Heart System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P180051	000

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 10 and 35 Degrees Celsius
Special Storage Condition, Specify: DO NOT STORE NEAR HEAT OR AN OPEN FLAME
Special Storage Condition, Specify: STORE WITH ADEQUATE VENTILATION

Clinically Relevant Size

[?]

Size Type Text
Length: 18 Inch
Width: 4 Inch
Height: 4 Inch

Device Record Status

Public Device Record Key: 25ddca65-3293-4858-b3e9-8d637531833f
Public Version Date: December 09, 2021
Public Version Number: 1
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
B00913603	2	B00913600		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

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