Catalog Number

1126098

Brand Name

Henry Schein

Version/Model Number

1126098

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

c2879bf1-00d7-476a-adaa-e0c3b0eeb2cc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10304040001957

Quantity per Package

5

Contains DI Package

00304040001950

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton