Catalog Number

KT-A27

Brand Name

NA

Version/Model Number

01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 16, 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

a30714bd-578b-4861-8331-e2a14d5da268

Public Version Date

January 18, 2021

Public Version Number

2

DI Record Publish Date

December 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-