Catalog Number

-

Brand Name

FetaLink®

Version/Model Number

FetaLink2013

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2016

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

K091251

Product Code

HGM

Product Code Name

System, Monitoring, Perinatal

Public Device Record Key

3130d792-6abe-4c42-b560-80463f101e3d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-