Identity
- Trade Name
- Bag, Breathing, 2-Liter Latex Free FDA UDI
- Generic Name
- Breathing circuit bag, single-use FDA UDI
- Device Name
- Bag, Breathing, 2-Liter Latex Free FDA UDI
- Model / Reference
- Bag, Breathing, 2-Liter Latex Free - 116201 FDA UDI
- Description
- Bag, Breathing, 2-Liter Latex Free FDA UDI
Identifiers
- Catalog Number
- 116201 FDA UDI
- Primary DI / UDI-DI
- 00817081023190 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breathing circuit bag, single-use
Bag, Breathing, 2-Liter Latex Free by A-M Systems, Inc. — 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
- 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- A-M Systems, Inc.
Sources (1)
- FDA UDI e957b916-ad1a-46aa-a365-749fd9eb1624 35 fields · synced May 30, 2026