Cohero - Peak flow and FEV1 meter - MIR SRL MEDICAL INTERNATIONAL RESEARCH

Duns Number:630129930

Device Description: Peak flow and FEV1 meter

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More Product Details

Catalog Number

911111

Brand Name

Cohero

Version/Model Number

cSpirometer

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K181666

Product Code Details

Product Code

BZH

Product Code Name

Meter, Peak Flow, Spirometry

Device Record Status

Public Device Record Key

859b5968-eed9-4fa7-b6db-5b9fd9ca0429

Public Version Date

March 19, 2021

Public Version Number

2

DI Record Publish Date

February 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIR SRL MEDICAL INTERNATIONAL RESEARCH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24