Catalog Number

-

Brand Name

MEDASSURE

Version/Model Number

DT007

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"

Yes

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

2ab9c7d7-28d4-4cf6-8269-dbac15b8857a

Public Version Date

May 19, 2022

Public Version Number

1

DI Record Publish Date

May 11, 2022

Package DI Number

66947656114094

Quantity per Package

200

Contains DI Package

06947656114092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cartoon