Catalog Number

-

Brand Name

Fetal Doppler FD-640G

Version/Model Number

FD-640G

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

fa644a68-111c-48ca-afed-9ce0de6386d4

Public Version Date

September 23, 2021

Public Version Number

1

DI Record Publish Date

September 15, 2021

Package DI Number

16970442090437

Quantity per Package

30

Contains DI Package

06970442090430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box