Catalog Number

-

Brand Name

LIFESENSE

Version/Model Number

TMB-1598-BN

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)

-

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

ccac8e56-d1d9-4c5c-abe3-7493ed975dd0

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

September 26, 2019

Package DI Number

26932825310058

Quantity per Package

20

Contains DI Package

16932825310051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton