Catalog Number

-

Brand Name

School Health

Version/Model Number

21-037-013-SH

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

f43dae56-6b16-4680-8b48-5fcbd0501f27

Public Version Date

July 22, 2019

Public Version Number

3

DI Record Publish Date

December 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-