Catalog Number

-

Brand Name

LUMISCOPE

Version/Model Number

2214.CE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

97574964-7a23-4543-8a5b-89e7f6d2de99

Public Version Date

July 25, 2019

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

M3682214CE3

Quantity per Package

48

Contains DI Package

M3682214CE2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-