Catalog Number

ZVCC4401F-1

Brand Name

N/A

Version/Model Number

ZVCC4401F-1

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

K082630,K082630

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

903ef9c3-152c-4830-9dfe-6113f41c67ab

Public Version Date

October 16, 2020

Public Version Number

1

DI Record Publish Date

October 08, 2020

Package DI Number

10607411933902

Quantity per Package

5

Contains DI Package

00607411933905

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-