Catalog Number

ACT2230Express Dual

Brand Name

Pelimex

Version/Model Number

ACT2230Express Dual

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 19, 2020

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

Yes

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

0f1ed7e4-1f55-47e4-bbb7-3e994de1f03b

Public Version Date

October 19, 2020

Public Version Number

3

DI Record Publish Date

October 20, 2016

Package DI Number

30471765290474

Quantity per Package

6

Contains DI Package

10471765290474

Package Discontinue Date

October 19, 2020

Package Status

Not in Commercial Distribution

Package Type

carton