Beurer - XL Cuff (33-43 cm) for use with Blood Pressure - BEURER NORTH AMERICA, L.P.

Duns Number:078497467

Device Description: XL Cuff (33-43 cm) for use with Blood Pressure Monitor Model # BM35 (Type BM35/1)

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More Product Details

Catalog Number

162.934

Brand Name

Beurer

Version/Model Number

BM35 XL Cuff (replacement) (Art.- No. 162.934)

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 13, 2020

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

9796b46e-2182-45ec-94c2-b8cd571489c8

Public Version Date

March 31, 2020

Public Version Number

6

DI Record Publish Date

June 12, 2017

Additional Identifiers

Package DI Number

10736211161915

Quantity per Package

50

Contains DI Package

00736211161918

Package Discontinue Date

January 13, 2020

Package Status

Not 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