Catalog Number

BJL-755

Brand Name

Bjingles

Version/Model Number

BJL-755

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

K110124,K110124

Product Code

KNG

Product Code Name

Monitor, Ultrasonic, Fetal

Public Device Record Key

8e770ee7-d57b-4520-ae0e-a706d90a5bdd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 22, 2016

Package DI Number

10861910000309

Quantity per Package

30

Contains DI Package

00861910000302

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box