Catalog Number

-

Brand Name

Fetal Doppler

Version/Model Number

HBL 16001WHT

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KNG

Product Code Name

Monitor, Ultrasonic, Fetal

Public Device Record Key

d4d222df-4caf-4ed6-a0cc-9d32f931c653

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 15, 2016

Package DI Number

10866755000286

Quantity per Package

4

Contains DI Package

00866755000289

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case