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OCS Liver System

FDA UDI

Class III (US FDA UDI)

by TransMedics, Inc

Identity

Trade Name
OCS Liver System FDA UDI
Generic Name
Donor-organ preservation/transport system gas refillable cylinder FDA UDI
Device Name
OCS Liver Gas Cylinder, Refill FDA UDI
Model / Reference
3406 FDA UDI
Description
OCS Liver Gas Cylinder, Refill FDA UDI

Identifiers

Catalog Number
3406 FDA UDI
Primary DI / UDI-DI
B00946650 FDA UDI
PMA Number
P200031 FDA UDI
FDA Product Code
QQK FDA UDI
GMDN Term
Donor-organ preservation/transport system gas refillable cylinder FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 18 Inch FDA UDI
Width — 4 Inch FDA UDI
Height — 4 Inch FDA UDI

Category: Donor-organ preservation/transport system gas refillable cylinder

OCS Liver System by TransMedics, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Donor-organ preservation/transport system gas refillable cylinder.

Cleared under the same submission

P200031 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
TransMedics, Inc

Sources (1)

  • FDA UDI a8ebfc71-f8e1-4a49-89d9-b578bbe73b98 38 fields · synced Jun 6, 2026