VentStar Bag Set 150

FDA UDI

Class I (US FDA UDI)

by Drägerwerk AG & Co. KGaA

Identity

Trade Name: VentStar Bag Set 150 FDA UDI
Generic Name: Breathing circuit bag, single-use FDA UDI
Model / Reference: MP00381 FDA UDI

Identifiers

Primary DI / UDI-DI: 04048675126522 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Breathing circuit bag, single-use

VentStar Bag Set 150 by Drägerwerk AG & Co. KGaA — Class I — 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
Breathing bags — Shandong Jinlai Huanhai Medical Technology Co., Ltd. · 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
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Drägerwerk AG & Co. KGaA

Sources (1)

FDA UDI e3cdcf21-38c4-4d4d-ad4a-6ba50942cb77 33 fields · synced May 30, 2026