Catalog Number

-

Brand Name

VCOMIN Fetal Doppler

Version/Model Number

FD-231D

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 24, 2020

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K182526

Product Code

KNG

Product Code Name

Monitor, Ultrasonic, Fetal

Public Device Record Key

e5513e5b-1291-4dd3-82bf-e18e9a58de8c

Public Version Date

November 26, 2020

Public Version Number

2

DI Record Publish Date

July 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-