Catalog Number

-

Brand Name

FC1400

Version/Model Number

FC1400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K043598,K043598

Product Code

HGM

Product Code Name

System, Monitoring, Perinatal

Public Device Record Key

5cdc5581-ef3a-411e-8eeb-f70f36410e42

Public Version Date

July 23, 2021

Public Version Number

1

DI Record Publish Date

July 15, 2021

Package DI Number

18809276943603

Quantity per Package

4

Contains DI Package

08809276943606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box