Identity
- Trade Name
- AincA® FDA UDI
- Generic Name
- Anaesthesia breathing circuit, reusable FDA UDI
- Device Name
- Arm, Universal Control, Single Tube System, Gauge, Bag Nipple, 22mmMx15mmF Outlet, w/00-118 APL Valve FDA UDI
- Model / Reference
- 00-115-S FDA UDI
- Description
- Arm, Universal Control, Single Tube System, Gauge, Bag Nipple, 22mmMx15mmF Outlet, w/00-118 APL Valve FDA UDI
Identifiers
- Catalog Number
- 00-115-S FDA UDI
- Primary DI / UDI-DI
- B00500115S0 FDA UDI
- 510(k) Number
- K833871 FDA UDI
- FDA Product Code
- CAI FDA UDI
- GMDN Term
- Anaesthesia breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anaesthesia breathing circuit, reusable
AincA® by Anesthesia Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia breathing circuit, reusable.
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- Sil.Plus — Galemed Corp. · Class I
- PORTER/BRN ADULT RG ASSY ONLY — Parker Hannifin Corp. · Class I
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC · Class II
- 30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW, AND LIMB, 2.4M — Intersurgical Incorporated · Class I
- Ultipor™ Anesthesia Breathing Circuit System - Pediatric Machine Kit — Global Life Sciences Solutions USA LLC · Class II
Cleared under the same submission
K833871 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 I | Pending data |
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Manufacturer
- Manufacturer
- Anesthesia Associates, Inc.
Sources (1)
- FDA UDI 623689bf-83a7-467e-bb87-40829998e112 36 fields · synced May 29, 2026