Catalog Number

-

Brand Name

FetaLink+®

Version/Model Number

FetaLink+4

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

K121758

Product Code

HGM

Product Code Name

System, Monitoring, Perinatal

Public Device Record Key

16c5de87-5262-463b-a52e-a6393ad32109

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-