Catalog Number

-

Brand Name

Tenacore

Version/Model Number

TFCU-PH05-2303

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

K043075

Product Code

HGM

Product Code Name

System, Monitoring, Perinatal

Public Device Record Key

a2a76061-ab11-4b41-8b85-07fab4c89803

Public Version Date

August 23, 2018

Public Version Number

4

DI Record Publish Date

October 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-