Catalog Number

-

Brand Name

VCOMIN Fetal Doppler

Version/Model Number

FD-540B

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

362d0d5d-d1cd-4be9-9667-e2e2730c567f

Public Version Date

December 02, 2020

Public Version Number

1

DI Record Publish Date

November 24, 2020

Package DI Number

16970442090000

Quantity per Package

30

Contains DI Package

06970442090003

Package Discontinue Date

November 29, 2020

Package Status

Not in Commercial Distribution

Package Type

box