DEVICE: OCS Liver System (B00950480)

Device Identifier (DI) Information

OCS Liver System
3000
In Commercial Distribution
3000
TRANSMEDICS, INC.
B00950480
HIBCC

1
084445043 *Terms of Use
OCS Liver Console
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
42919 Liver donor-organ preservation/transport system
A dedicated system designed to support and maintain a donated liver organ during transport from the donor to the receiver hospital where the organ will be transplanted into the recipient. This system will provide technical support functions to keep the organ in as near-physiologic state as possible.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QQK Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P200031 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
Length: 17 Inch
Height: 29 Inch
Width: 28 Inch
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Device Record Status

f6c811bf-174a-4137-bd9b-61fcd3fb4b60
December 09, 2021
1
December 01, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B00950491 1 B00950480 In Commercial Distribution Wooden Crate
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
978-552-0900
xx@xx.xx
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