Catalog Number

-

Brand Name

CVSHealth

Version/Model Number

BPAG1-20CVS

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

K092245,K092245,K092245

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

20c01ca3-6d8e-480a-87c7-3e22ea6636d5

Public Version Date

December 07, 2018

Public Version Number

4

DI Record Publish Date

October 14, 2016

Package DI Number

10050428272883

Quantity per Package

12

Contains DI Package

00050428272886

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton