Catalog Number

-

Brand Name

belter

Version/Model Number

TE-91

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

K140681,K140681,K140681

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

9c51e6b4-d6a1-482d-8fe6-16a35c4d6449

Public Version Date

May 11, 2020

Public Version Number

1

DI Record Publish Date

May 02, 2020

Package DI Number

16947468500011

Quantity per Package

1

Contains DI Package

06947468500014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pcs/box