Catalog Number

-

Brand Name

OctiveTech

Version/Model Number

FDIR-V1

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

K052849,K052849

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

6776c449-e72d-4748-bb76-6db84c2bc235

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

October 04, 2016

Package DI Number

10897429002053

Quantity per Package

60

Contains DI Package

00897429002056

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case