Identity
- Trade Name
- PFM FDA UDI
- Generic Name
- Expiratory peak flow meter, analogue, reusable FDA UDI
- Device Name
- my PEF PEAK FLOW METER FDA UDI
- Model / Reference
- 4300 FDA UDI
- Description
- my PEF PEAK FLOW METER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05099169439504 FDA UDI
- 510(k) Number
- K781922 FDA UDI
- FDA Product Code
- BXW FDA UDI
- GMDN Term
- Expiratory peak flow meter, analogue, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.1870 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
No
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: Expiratory peak flow meter, analogue, reusable
Pfm by Vitalograph Ireland, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Expiratory peak flow meter, analogue, reusable.
- Mini Wright — CLEMENT CLARKE INTERNATIONAL LIMITED · Class II
- Tenovi — TENOVI CO · Class II
- Airzone — CLEMENT CLARKE INTERNATIONAL LIMITED · Class II
- PFM — Vitalograph Ireland, Ltd. · Class II
- PFM — Vitalograph Ireland, Ltd. · Class I
- PFM — Vitalograph Ireland, Ltd. · Class II
- PFM — Vitalograph Ireland, Ltd. · Class II
Cleared under the same submission
K781922 also covers:
- PFM — Vitalograph Ireland, Ltd.
- PFM — Vitalograph Ireland, Ltd.
- PFM — Vitalograph Ireland, Ltd.
- PFM — Vitalograph Ireland, Ltd.
- PFM — Vitalograph Ireland, Ltd.
- PFM — Vitalograph Ireland, Ltd.
- PFM — Vitalograph Ireland, Ltd.
- PFM — Vitalograph Ireland, Ltd.
- PFM — Vitalograph Ireland, Ltd.
- PFM — Vitalograph Ireland, Ltd.
- PFM — Vitalograph Ireland, Ltd.
- PFM — Vitalograph Ireland, Ltd.
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
- Vitalograph Ireland, Ltd.
Sources (1)
- FDA UDI 9119657d-703d-41ee-887b-1b6aadd96b20 35 fields · synced Jun 8, 2026