Catalog Number

-

Brand Name

VCOMIN Fetal Doppler

Version/Model Number

FD-640D

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182526,K182526

Product Code

KNG

Product Code Name

Monitor, Ultrasonic, Fetal

Public Device Record Key

fc46f962-cd88-4a66-9e4f-cb9746dc4840

Public Version Date

November 26, 2020

Public Version Number

2

DI Record Publish Date

July 15, 2020

Package DI Number

16970442090079

Quantity per Package

20

Contains DI Package

06970442090072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box