Identity
- Trade Name
- PersonalBest EUDAMEDPERSONAL BEST FDA UDI
- Generic Name
- Peak flow meter, manual FDA UDI
- Device Name
- PERSONAL BEST FR PFM ISO-23747 SINGLE FDA UDI
- Model / Reference
- Personal Best EUDAMED1022973 EUDAMED00 FDA UDI
- Description
- PERSONAL BEST FR PFM ISO-23747 SINGLE FDA UDI
Identifiers
- Catalog Number
- 1022973 FDA UDI
- Primary DI / UDI-DI
- 00383730000404 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00383730000404 EUDAMED
- 510(k) Number
- K912866 FDA UDI
- FDA Product Code
- BZH FDA UDI
- EMDN Code
- Z12150102 PEAK FLOW SPIROMETERS EUDAMED
- GMDN Term
- Peak flow meter, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1860 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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, digital
PersonalBest by Respironics Respiratory Drug Delivery (uk) Ltd — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Expiratory peak flow meter, digital.
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- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00383730000404 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Respironics Respiratory Drug Delivery (UK) Ltd
- EUDAMED SRN
- GB-MF-000002292
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 1fa20cee-b2ba-489d-bf66-17f5d2fafc30 61 fields · synced Jun 8, 2026
- FDA UDI b2ebccb8-b87a-4cc8-ba04-061a137d1fd7 36 fields · synced May 30, 2026