Catalog Number

KT-A04

Brand Name

NA

Version/Model Number

01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 30, 2021

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"

-

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

K081951

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

08338166-dff2-4c03-afc7-3bf5d304af07

Public Version Date

February 01, 2021

Public Version Number

2

DI Record Publish Date

December 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-