Catalog Number

-

Brand Name

Temp Probe

Version/Model Number

Temp Probe

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

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

K962070,K962070

Product Code

FLL

Product Code Name

Thermometer, electronic, clinical

Public Device Record Key

a3dc793a-6c09-4d20-a7f6-6cdd5e94a99c

Public Version Date

August 15, 2018

Public Version Number

3

DI Record Publish Date

May 30, 2018

Package DI Number

10803622140225

Quantity per Package

2

Contains DI Package

00803622140228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE