Identity
- Trade Name
- AincA® FDA UDI
- Generic Name
- Endotracheal tube cuff inflator FDA UDI
- Device Name
- Tubing, Replacement, 100cm (39in) LuerF x LuerM Extension. Used on 00-197, (10) Tubing sets FDA UDI
- Model / Reference
- 00-197-TUBING FDA UDI
- Description
- Tubing, Replacement, 100cm (39in) LuerF x LuerM Extension. Used on 00-197, (10) Tubing sets FDA UDI
Identifiers
- Catalog Number
- 00-197-TUBING FDA UDI
- Primary DI / UDI-DI
- B00500197TUBING3 FDA UDI
- 510(k) Number
- K912723 FDA UDI
- FDA Product Code
- BSK FDA UDI
- GMDN Term
- Endotracheal tube cuff inflator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5750 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
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
MR Safe FDA UDI
Category: Endotracheal tube cuff inflator
AincA® by Anesthesia Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endotracheal tube cuff inflator.
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- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K912723 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Anesthesia Associates, Inc.
Sources (1)
- FDA UDI 1e3f698b-8d72-4daf-83cf-af8b1bd33c24 36 fields · synced Jun 8, 2026