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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
Portable spirometer for lung function testing with oximetry function FDA UDI
Model / Reference
Spirobank II PLUS FDA UDI
Description
Portable spirometer for lung function testing with oximetry function FDA UDI

Identifiers

Primary DI / UDI-DI
08052990322213 FDA UDI
510(k) Number
K061712 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

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.

Cleared under the same submission

K061712 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mir Medical International Research

Sources (1)

  • FDA UDI 21fb3d5d-406d-4f85-b618-b6857dc46296 35 fields · synced May 30, 2026