Catalog Number

20634

Brand Name

TIDI

Version/Model Number

20634

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

6a173961-d1c9-4fd9-82a9-0a2b4a50c2c9

Public Version Date

August 23, 2021

Public Version Number

3

DI Record Publish Date

October 04, 2016

Package DI Number

10618125101884

Quantity per Package

10

Contains DI Package

00618125101887

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-