Catalog Number

-

Brand Name

NA

Version/Model Number

KT-A05

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

2eaae218-a275-4a74-afd6-108479a7f7e4

Public Version Date

November 30, 2021

Public Version Number

1

DI Record Publish Date

November 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-