Catalog Number

ZVCC4301X-1

Brand Name

N/A

Version/Model Number

ZVCC4301X-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

bc65d76a-adec-4fe3-b0d4-8bf086fb43c1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 09, 2017

Package DI Number

10607411933797

Quantity per Package

5

Contains DI Package

00607411933790

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-