Catalog Number

-

Brand Name

Dagamma

Version/Model Number

DT1000

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

K131243

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

6a1eff42-bc96-4c57-a717-a888e1d09f59

Public Version Date

December 04, 2020

Public Version Number

5

DI Record Publish Date

March 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-