Mir

FDA UDI

Class II (US FDA UDI)

by Mir Medical International Research

Identity

Trade Name: MIR FDA UDI
Generic Name: Expiratory peak flow meter, digital FDA UDI
Device Name: Desktop base spirometer and oximeter for lung function testing FDA UDI
Model / Reference: Spirolab PLUS FDA UDI
Description: Desktop base spirometer and oximeter for lung function testing FDA UDI

Identifiers

Primary DI / UDI-DI: 08052990320264 FDA UDI
510(k) Number: K122384 FDA UDI
FDA Product Code: BZG FDA UDI
DQA FDA UDI
GMDN Term: Expiratory peak flow meter, digital FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1840 FDA UDI
870.2700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Expiratory peak flow meter, digital

Mir by Mir Medical International Research — Class II — FDA UDI — listed in FDA GUDID — 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

K122384 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

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Manufacturer

Manufacturer: Mir Medical International Research

Sources (1)

FDA UDI 8c518c55-3928-42c8-a7ed-7a02172270ec 35 fields · synced May 30, 2026