Catalog Number

-

Brand Name

All Purpose Cuff

Version/Model Number

98-0084-09

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

K051904

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

7d71458e-86b2-4b9d-88d9-1fce35d5d49f

Public Version Date

October 22, 2021

Public Version Number

1

DI Record Publish Date

October 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-