Catalog Number

-

Brand Name

blood pressure cuff, Size XL, for digital devices

Version/Model Number

A2534-xl

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)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

bc93a9c8-49ed-42cd-819b-03b78d51767e

Public Version Date

December 29, 2020

Public Version Number

1

DI Record Publish Date

December 21, 2020

Package DI Number

14260671372582

Quantity per Package

20

Contains DI Package

04260671372585

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-