Catalog Number

BJL-995

Brand Name

Bjingles

Version/Model Number

BJL-995

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

K171214,K171214

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

5758f220-be97-4ef4-9e63-ffc4c164bc59

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

April 23, 2018

Package DI Number

10861910000347

Quantity per Package

100

Contains DI Package

00861910000340

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box