microlife - MICROLIFE USA, INC.

Duns Number:176387785

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More Product Details

Catalog Number

-

Brand Name

microlife

Version/Model Number

PF100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

BZH

Product Code Name

Meter, Peak Flow, Spirometry

Device Record Status

Public Device Record Key

a6436b5a-6209-440e-a9bd-a6d17736dd91

Public Version Date

March 19, 2021

Public Version Number

3

DI Record Publish Date

May 19, 2017

Additional Identifiers

Package DI Number

10642632732002

Quantity per Package

12

Contains DI Package

00642632732005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton packing

"MICROLIFE USA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 27