Catalog Number

1952-1

Brand Name

TEMPTRAC®

Version/Model Number

1952-1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K830530,K830530

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

dcca6e94-9b0b-4cd7-9e35-e9f3118b0a27

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 12, 2018

Package DI Number

10650551046322

Quantity per Package

12

Contains DI Package

00650551046325

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX