AccessGUDID - DEVICE: OCS Heart System (B00926340)

GUDID

Device Identifier (DI) Information

Brand Name: OCS Heart System
Version or Model: 1300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1300
Company Name: TRANSMEDICS, INC.

Primary DI Number: B00926340
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084445043 *Terms of Use

Device Description: OCS Heart Solution 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?
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
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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 10 and 106 KiloPascal
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 25 Degrees Celsius
Special Storage Condition, Specify: DO NOT GET WET
Special Storage Condition, Specify: DO NOT EXPOSE TO DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Length: 20 Inch
Width: 15 Inch
Height: 3 Inch

Device Record Status

Public Device Record Key: 0c0fa2f7-22eb-4be0-9877-59af232844a7
Public Version Date: December 08, 2022
Public Version Number: 2
DI Record Publish Date: December 01, 2021