Latex-free Breathing Bag - 2 Liter

FDA UDI

Class II (US FDA UDI)

by Global Life Sciences Solutions USA LLC

Identity

Trade Name: Latex-free Breathing Bag - 2 Liter FDA UDI
Generic Name: Breathing circuit bag, single-use FDA UDI
Device Name: Latex-free Breathing Bag - 2 Liter FDA UDI
Model / Reference: VM2LBB20 FDA UDI
Description: Latex-free Breathing Bag - 2 Liter FDA UDI

Identifiers

Catalog Number: VM2LBB20 FDA UDI
Primary DI / UDI-DI: 00636207315410 FDA UDI
510(k) Number: K013093 FDA UDI
FDA Product Code: CAH FDA UDI
GMDN Term: Breathing circuit bag, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5260 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Total Volume — 2 Liter FDA UDI

Category: Breathing circuit bag, single-use

Latex-free Breathing Bag - 2 Liter by Global Life Sciences Solutions USA LLC — Class II — 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
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

Cleared under the same submission

K013093 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Global Life Sciences Solutions USA LLC

Sources (1)

FDA UDI e8248cfe-5ec3-4a23-8515-845eeb4c186f 37 fields · synced May 30, 2026