Catalog Number

ZDC4312F-NEOP

Brand Name

N/A

Version/Model Number

ZDC4312F-NEOP

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

K080366,K080366

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

918b9e9e-51da-44a0-85ea-23a22e2925b9

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

May 12, 2017

Package DI Number

10607411940597

Quantity per Package

5

Contains DI Package

00607411940590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-