Catalog Number

MDS9118

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

MDS9118

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

K090014

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

7c887c07-5bdd-4e4c-82e4-552c41e4ebf9

Public Version Date

December 04, 2020

Public Version Number

1

DI Record Publish Date

November 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-