Catalog Number

-

Brand Name

CIRCA Temperature Monitoring System

Version/Model Number

CS-1000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 28, 2017

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K112376

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

b5cbeb9e-f2aa-45b0-aa3b-ead339d525d0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-