Catalog Number

-

Brand Name

Pro Temp Oral Thermometer

Version/Model Number

BT-A21CN

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101387,K101387,K101387

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

a6b117c1-ec80-4dd0-9865-d8a86e3324fb

Public Version Date

May 13, 2020

Public Version Number

1

DI Record Publish Date

May 05, 2020

Package DI Number

10850632007581

Quantity per Package

30

Contains DI Package

00850632007584

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Case