Catalog Number

416-5000

Brand Name

Adtemp™

Version/Model Number

416-5000

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

K940686

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

7b72cf93-5b3b-4623-93c4-9fdfeeac725e

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-