Catalog Number

-

Brand Name

TupeloLife

Version/Model Number

TBP-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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123780,K123780

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

688d706c-8528-49f1-a95d-2259737582cb

Public Version Date

December 04, 2020

Public Version Number

1

DI Record Publish Date

November 26, 2020

Package DI Number

10860005787200

Quantity per Package

10

Contains DI Package

00860005787203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton