Catalog Number

-

Brand Name

Blue Cross Blue Shield/HealthSmart

Version/Model Number

171-655-001

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

d276295f-7837-4476-9017-e65fef2c53f8

Public Version Date

November 17, 2020

Public Version Number

1

DI Record Publish Date

November 09, 2020

Package DI Number

30767056180698

Quantity per Package

3

Contains DI Package

00767056180697

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton