Catalog Number

-

Brand Name

Medline

Version/Model Number

MDS9913HP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 2019

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K032821,K032821

Product Code

NPP

Product Code Name

Reprocessed Blood Pressure Cuff

Public Device Record Key

11ef9a82-1b83-4d1f-963e-550f20dd4205

Public Version Date

March 19, 2021

Public Version Number

4

DI Record Publish Date

February 04, 2017

Package DI Number

30817357022149

Quantity per Package

20

Contains DI Package

10817357022145

Package Discontinue Date

March 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Box