Catalog Number

-

Brand Name

Beurer

Version/Model Number

BM47 XL Cuff (replacement) (Item No. 163.859)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

1c6cbef3-539c-44dd-b3c3-bad6ddfd41d5

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

March 15, 2017

Package DI Number

10852547004457

Quantity per Package

20

Contains DI Package

00852547004450

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE PACK