Catalog Number

-

Brand Name

RITE AID

Version/Model Number

TE-97

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

6cdeac3d-bfae-4536-8a0f-7092423985f2

Public Version Date

August 17, 2022

Public Version Number

1

DI Record Publish Date

August 09, 2022

Package DI Number

16947468500288

Quantity per Package

1

Contains DI Package

06947468500397

Package Discontinue Date

August 09, 2022

Package Status

Not in Commercial Distribution

Package Type

-