Catalog Number

-

Brand Name

biotricity

Version/Model Number

TE-107

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"

Yes

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

3e24a91a-3afc-4479-b61c-f7d562fccb17

Public Version Date

December 09, 2021

Public Version Number

1

DI Record Publish Date

December 01, 2021

Package DI Number

16947468500233

Quantity per Package

1

Contains DI Package

06947468500335

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PCS/BOX