Catalog Number

760-11ALEOKOIQ

Brand Name

Prosphyg™

Version/Model Number

760-11ALEOKOIQ

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"

-

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

1ca00aae-129b-4cc2-9044-3b1889269ebb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

00843515000154

Quantity per Package

14

Contains DI Package

00843515234467

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case