Halyard Breathing Bag

FDA UDI

Class I (US FDA UDI)

by Airlife, Inc.

Identity

Trade Name: Halyard Breathing Bag FDA UDI
Generic Name: Breathing circuit bag, single-use FDA UDI
Device Name: Halyard Breathing Bag FDA UDI
Model / Reference: ABC3002 FDA UDI
Description: Halyard Breathing Bag FDA UDI

Identifiers

Primary DI / UDI-DI: 10885632455421 FDA UDI
FDA Product Code: BTC FDA UDI
GMDN Term: Breathing circuit bag, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Breathing circuit bag, single-use

Halyard Breathing Bag by Airlife, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Breathing circuit bag, single-use.

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2 LITER CONTOUR® — KING SYSTEMS CORPORATION. · 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
Bag, Breathing, 3-Liter Latex Free — A-M Systems, Inc. · 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 I	Pending data

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Manufacturer

Manufacturer: Airlife, Inc.

Sources (1)

FDA UDI 0beb91b9-bf27-48df-8a1c-2556c792d84d 33 fields · synced Jun 8, 2026