Catalog Number

9000TP

Brand Name

Adview

Version/Model Number

9000TP

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

K070750,K070750,K070750

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

aa5aa366-c5d5-4cf7-a960-27ba04d111c6

Public Version Date

August 31, 2018

Public Version Number

1

DI Record Publish Date

July 31, 2018

Package DI Number

00634782065201

Quantity per Package

10

Contains DI Package

00634782564650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master