Catalog Number

-

Brand Name

Disposable adult thigh blood cuff(CM1505)

Version/Model Number

115-054846-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182821,K182821

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

031f1ee9-2abe-462c-a59b-11b4a11a686a

Public Version Date

August 05, 2020

Public Version Number

1

DI Record Publish Date

July 28, 2020

Package DI Number

06944904005317

Quantity per Package

10

Contains DI Package

06936415903992

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-