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OCS Heart System

FDA UDI

Class III (US FDA UDI)

by TransMedics, Inc

Identity

Trade Name
OCS Heart System FDA UDI
Generic Name
Heart donor-organ preservation/transport system FDA UDI
Device Name
OCS Heart Console FDA UDI
Model / Reference
1000 FDA UDI
Description
OCS Heart Console FDA UDI

Identifiers

Catalog Number
1000 FDA UDI
Primary DI / UDI-DI
B00949290 FDA UDI
PMA Number
P180051 FDA UDI
FDA Product Code
QIK FDA UDI
GMDN Term
Heart donor-organ preservation/transport system 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 17 Inch FDA UDI
Width — 28 Inch FDA UDI
Height — 29 Inch FDA UDI

Category: Heart donor-organ preservation/transport system

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

Cleared under the same submission

P180051 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 cc512d77-65e9-4ba8-a36f-6291023872b8 38 fields · synced May 31, 2026