Catalog Number

ZCC4001MQM-1

Brand Name

N/A

Version/Model Number

ZCC4001MQM-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

K921997,K921997

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

10dbd950-b5e8-4294-be57-3b23a4ddd288

Public Version Date

July 19, 2018

Public Version Number

4

DI Record Publish Date

February 20, 2017

Package DI Number

01060741190551

Quantity per Package

10

Contains DI Package

00607411940552

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-