Identity
- Trade Name
- AincA® FDA UDI
- Generic Name
- Breathing circuit bag, reusable FDA UDI
- Device Name
- Bag, Breathing, FLUTED, 22mmF Rubber Bushing, 3 liter, Conductive Neoprene FDA UDI
- Model / Reference
- E-198 FDA UDI
- Description
- Bag, Breathing, FLUTED, 22mmF Rubber Bushing, 3 liter, Conductive Neoprene FDA UDI
Identifiers
- Catalog Number
- E-198 FDA UDI
- Primary DI / UDI-DI
- B005E1980 FDA UDI
- FDA Product Code
- BTC FDA UDI
- GMDN Term
- Breathing circuit bag, reusable 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 3 Liter FDA UDI
Category: Breathing circuit bag, reusable
AincA® by Anesthesia Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Breath bag set Anest 22mm Hytrel — 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 |
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Manufacturer
- Manufacturer
- Anesthesia Associates, Inc.
Sources (1)
- FDA UDI 2a5cad6e-c663-4b8d-9fa6-70d7a3ec6ee4 36 fields · synced May 31, 2026