AccessGUDID - DEVICE: Organ Care System (B00925681)

GUDID

Device Identifier (DI) Information

Brand Name: Organ Care System
Version or Model: 1423
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1423
Company Name: TRANSMEDICS, INC.

Primary DI Number: B00925681
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084445043 *Terms of Use

Device Description: OCS Regulator Yoke Gasket

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?
62815	Gas/fluid regulator gasket	A small circular device intended to be inserted into the joint between a gas/fluid regulator and the gas/fluid supply cylinder to which the regulator is attached, to create a seal for the prevention of gas/fluid leaks. It is made of compressible material (e.g., paper, rubber, asbestos). This is a reusable device.	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

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 Temperature: between -20 and 50 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Height: 0.08 Inch
Width: 0.6 Inch
Length: 0.6 Inch

Device Record Status

Public Device Record Key: 3c72e528-5ec1-44a9-8ffe-fc43e7d29957
Public Version Date: July 02, 2018
Public Version Number: 1
DI Record Publish Date: June 01, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B00954003	1	B00925681		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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 9785520900
Email: xx@xx.xx

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