Beurer - BM47 Universal Cuff (replacement) - BEURER NORTH AMERICA, L.P.

Duns Number:078497467

Device Description: BM47 Universal Cuff (replacement)

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More Product Details

Catalog Number

-

Brand Name

Beurer

Version/Model Number

BM47 Universal Cuff (replacement)

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

b7f466cc-3354-440a-909b-500d8a436663

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10852547004600

Quantity per Package

20

Contains DI Package

00852547004603

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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