Catalog Number

-

Brand Name

Fetal monitor

Version/Model Number

FM-2000

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

-

Product Code

HGL

Product Code Name

Transducer, Ultrasonic, Obstetric

Public Device Record Key

4bc4a094-6702-4593-aa23-86f6c0f3fc74

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-