Catalog Number

-

Brand Name

Disposable Cuff

Version/Model Number

98-0500-96

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080854,K080854

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

0ac26e22-c810-41e7-b827-d4f1cdf38d67

Public Version Date

August 28, 2020

Public Version Number

1

DI Record Publish Date

August 20, 2020

Package DI Number

20840935109331

Quantity per Package

20

Contains DI Package

10840935109334

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box