Identity
- Trade Name
- Smart One Oxi EUDAMEDMIR FDA UDI
- Generic Name
- Expiratory peak flow meter, digital FDA UDI
- Device Name
- Smart Spirometer and Oximeter connected to an app available on a smart phone FDA UDI
- Model / Reference
- MIR065 EUDAMED911120 - 911120B0 EUDAMEDSmart One Oxi FDA UDI
- Description
- Smart Spirometer and Oximeter connected to an app available on a smart phone FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08052990321704 EUDAMEDFDA UDI
- Basic UDI-DI
- 805299032065O4Z EUDAMED
- 510(k) Number
- K230501 FDA UDI
- FDA Product Code
- BZG FDA UDIDQA FDA UDI
- EMDN Code
- Z12150102 PEAK FLOW SPIROMETERS EUDAMED
- GMDN Term
- Expiratory peak flow meter, digital FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1840 FDA UDI870.2700 FDA UDI
- Market of Registration
- Italy 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Pulse oximeterExpiratory peak flow meter, digital
Mir by Mir Medical International Research — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Expiratory peak flow meter, digital.
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Spirolab — MIR - Medical International Research S.p.A. · Class IIa
- Spirolab Plus — MIR - Medical International Research S.p.A. · Class IIa
- NxGen Peak Flow Meter — SAFEY MEDICAL DEVICES PRIVATE LIMITED · Class II
- Spirosound — Medset Medizintechnik GmbH · Class IIa
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mir Medical International Research
Sources (2)
- FDA UDI 94a7a668-bab6-4ea9-b090-4d283915eaaf 35 fields · synced Jul 13, 2026
- EUDAMED ebd2f36c-d22c-4cdb-b9b3-e2bdfe31763b 61 fields · synced Jul 13, 2026