Catalog Number

ZSC4102X-1

Brand Name

N/A

Version/Model Number

ZSC4122X-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

Yes

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

345affc0-eb9c-4a63-b705-a2c8a501d0cc

Public Version Date

October 08, 2020

Public Version Number

1

DI Record Publish Date

September 30, 2020

Package DI Number

10607411938839

Quantity per Package

10

Contains DI Package

00607411938832

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-