Catalog Number

Type BM35/1 (654.69)

Brand Name

CVS Health

Version/Model Number

800231

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

8ade0d4b-286b-436e-ad3a-b2d2d16336eb

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

August 26, 2019

Package DI Number

10050428438265

Quantity per Package

12

Contains DI Package

00050428438268

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack