Catalog Number

-

Brand Name

Blood Pressure Multi-5 Cuff Kit

Version/Model Number

7098

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

K043286

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

0a5ca3db-fd63-4793-b1c7-a6ec4bb58f19

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-