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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
Extracorporeal blood parameter probe FDA UDI
Device Name
SvO2/HCT Probe FDA UDI
Model / Reference
1427 FDA UDI
Description
SvO2/HCT Probe FDA UDI

Identifiers

Catalog Number
1427 FDA UDI
Primary DI / UDI-DI
B00925751 FDA UDI
PMA Number
P180051 FDA UDI
FDA Product Code
QIK FDA UDI
GMDN Term
Extracorporeal blood parameter probe 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

No

FDA UDI

Dimensions & Sizes

Size
Length — 9 Inch FDA UDI
Width — 5.13 Inch FDA UDI
Height — 2.3 Inch FDA UDI

Category: Extracorporeal blood parameter probe

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 893ef5dc-6e45-464c-8513-4d826841fa63 38 fields · synced May 30, 2026