Catalog Number

-

Brand Name

Sweetiesong Fetal Doppler

Version/Model Number

EZD-100S5

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

K131457,K131457

Product Code

KNG

Product Code Name

Monitor, Ultrasonic, Fetal

Public Device Record Key

3e0ea882-e22c-44a0-8475-e4267260b040

Public Version Date

April 06, 2020

Public Version Number

5

DI Record Publish Date

August 01, 2016

Package DI Number

10850253007083

Quantity per Package

30

Contains DI Package

00850253007086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-