OCS Lung System

FDA UDI

Class III (US FDA UDI)

by TransMedics, Inc

Identity

Trade Name: OCS Lung System FDA UDI
Generic Name: Breathing circuit bag, single-use FDA UDI
Device Name: OCS Lung Manual Inflation Set FDA UDI
Model / Reference: 2404 FDA UDI
Description: OCS Lung Manual Inflation Set FDA UDI

Identifiers

Catalog Number: 2404 FDA UDI
Primary DI / UDI-DI: B00940001 FDA UDI
FDA Product Code: QBA FDA UDI
GMDN Term: Breathing circuit bag, single-use 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 4 Inch FDA UDI
Width — 12 Inch FDA UDI
Length — 18 Inch FDA UDI

Category: Breathing circuit bag, single-use

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

Similar devices

Also classified as Breathing circuit bag, single-use.

BREATHING BAG — KING SYSTEMS CORPORATION. · Class I
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VentStar Anesthesia WT 180 — Drägerwerk AG & Co. KGaA · Class I
2 LITER CONTOUR® — KING SYSTEMS CORPORATION. · Class I
Halyard Breathing Bag — Airlife, Inc. · Class I
Breathing bags — Shandong Jinlai Huanhai Medical Technology Co., Ltd. · Class I
Breathing bags — Shandong Jinlai Huanhai Medical Technology Co., Ltd. · Class I
Breathing bag anest disp 1L compl — Maquet Critical Care AB · Class I

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 4f36f3bb-5da2-40b3-9dba-12bca784dd1d 37 fields · synced May 30, 2026