Catalog Number

-

Brand Name

TriageHF™

Version/Model Number

5242

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P890003

Product Code

NVZ

Product Code Name

Pulse generator, permanent, implantable

Public Device Record Key

c361a016-4f82-4ee1-896f-2949ecfa19c0

Public Version Date

July 31, 2020

Public Version Number

1

DI Record Publish Date

July 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-