Catalog Number

FMC6469

Brand Name

Faichney Medical Company

Version/Model Number

FMC6469

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 07, 2017

Issuing Agency

In HIBCC

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

4bb008f8-22db-47a7-8754-4502d09dbb79

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-