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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
Diagnostic spirometer, professional FDA UDI
Device Name
Desktop base spirometer for lung function testing with Bluetooth function FDA UDI
Model / Reference
Spirolab New spirometer Light Bluetooth FDA UDI
Description
Desktop base spirometer for lung function testing with Bluetooth function FDA UDI

Identifiers

Catalog Number
911080GB FDA UDI
Primary DI / UDI-DI
08052990321674 FDA UDI
510(k) Number
K061875 FDA UDI
FDA Product Code
BZG FDA UDI
GMDN Term
Diagnostic spirometer, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1840 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: Diagnostic spirometer, professional

Mir by Mir Medical International Research — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic spirometer, professional.

Cleared under the same submission

K061875 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 b360a3e5-1395-4c61-9db9-efae37e6d18c 35 fields · synced Jun 8, 2026