Identity
- Trade Name
- AincA® FDA UDI
- Generic Name
- Peak flow meter, manual FDA UDI
- Device Name
- Peak Flow Meter, Trainer, Windmill, fits LowRange Mini-Wright FDA UDI
- Model / Reference
- 00-174-2 FDA UDI
- Description
- Peak Flow Meter, Trainer, Windmill, fits LowRange Mini-Wright FDA UDI
Identifiers
- Catalog Number
- 00-174-2 FDA UDI
- Primary DI / UDI-DI
- B0050017420 FDA UDI
- 510(k) Number
- K851265 FDA UDI
- FDA Product Code
- BZH FDA UDI
- GMDN Term
- Peak flow meter, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1860 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
Category: Peak flow meter, manual
AincA® by Anesthesia Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K851265 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 f1ee06fd-96dd-4246-a9ef-bc7eca258f0e 36 fields · synced May 30, 2026