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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
Exsanguination set FDA UDI
Device Name
OCS Blood Collection Set FDA UDI
Model / Reference
1400 FDA UDI
Description
OCS Blood Collection Set FDA UDI

Identifiers

Catalog Number
1400 FDA UDI
Primary DI / UDI-DI
B00918043 FDA UDI
PMA Number
P180051 FDA UDI
FDA Product Code
QIK FDA UDI
GMDN Term
Exsanguination set FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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 — 12 Inch FDA UDI
Height — 4 Inch FDA UDI

Category: Exsanguination set

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 b750e4b5-544c-42a4-b566-634d825d0294 38 fields · synced May 30, 2026