OCS Heart System

FDA UDI

Class III (US FDA UDI)

by TransMedics, Inc

Identity

Trade Name: OCS Heart System FDA UDI
Generic Name: Extracorporeal fluid flow probe FDA UDI
Device Name: Aortic Flow Probe FDA UDI
Model / Reference: 1424 FDA UDI
Description: Aortic Flow Probe FDA UDI

Identifiers

Catalog Number: 1424 FDA UDI
Primary DI / UDI-DI: B00925721 FDA UDI
PMA Number: P180051 FDA UDI
FDA Product Code: QIK FDA UDI
GMDN Term: Extracorporeal fluid flow probe FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

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

Category: Extracorporeal fluid flow probe

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

Similar devices

Also classified as Extracorporeal fluid flow probe.

ADULT FLOW PROBE 3/8" X 3/32" — Thoratec Switzerland GmbH · Class II
INSPIRA ART100 — Inspira Technologies Oxy B.H.N. , Ltd. · Class II
EM-TEC ADULT FLOW PROBE FOR 2ND GEN CENTRIMAG PRIMARY CONSOLE — Thoratec Switzerland GmbH · Class II
INSPIRA ART100 — Inspira Technologies Oxy B.H.N. , Ltd. · Class II
PEDIATRIC FLOW PROBE 1/4" X 3/32" — Thoratec Switzerland GmbH · Class II
EM-TEC PEDIATRIC FLOW PROBE FOR 2ND GEN CENTRIMAG PRIMARY CONSOLE — Thoratec Switzerland GmbH · Class II
Organ Care System — TransMedics, Inc · Class III
OCS Heart System — TransMedics, Inc · Class III

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: TransMedics, Inc

Sources (1)

FDA UDI 34b1f3e5-ca23-4dc5-99c7-7c2fe0508950 38 fields · synced May 30, 2026