Catalog Number

-

Brand Name

Famidoc

Version/Model Number

FDIR-V2

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

K113761,K113761

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

b7699d9b-aac8-4ef0-813e-e5a8e4e87dc1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 29, 2016

Package DI Number

10854314007104

Quantity per Package

40

Contains DI Package

00854314007107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-