microlife - MICROLIFE USA, INC.

Duns Number:176387785

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More Product Details

Catalog Number

-

Brand Name

microlife

Version/Model Number

PF101

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

c996de5f-75eb-4a18-842b-c37baa41849c

Public Version Date

June 10, 2022

Public Version Number

1

DI Record Publish Date

June 02, 2022

Additional Identifiers

Package DI Number

10642632732057

Quantity per Package

2

Contains DI Package

00642632732050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box 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