Beurer - BF70 Bluetooth® Diagnostic Scale - BEURER NORTH AMERICA, L.P.

Duns Number:078497467

Device Description: BF70 Bluetooth® Diagnostic Scale

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More Product Details

Catalog Number

-

Brand Name

Beurer

Version/Model Number

BF70 (Art.-No. 747.70)

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

PUH

Product Code Name

Analyzer, Body Composition, Exempt

Device Record Status

Public Device Record Key

1c35a98e-f210-420c-8122-08eb71f7b8fb

Public Version Date

February 25, 2019

Public Version Number

4

DI Record Publish Date

May 08, 2017

Additional Identifiers

Package DI Number

10853879007062

Quantity per Package

4

Contains DI Package

00853879007065

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack

"BEURER NORTH AMERICA, L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 90
U Unclassified 2