Catalog Number

413KM

Brand Name

Kerma

Version/Model Number

413KM

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

fe1caf8f-868a-46b4-a3b6-e3473a026c78

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 30, 2017

Package DI Number

00634782595272

Quantity per Package

6

Contains DI Package

00634782895273

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case