Catalog Number

IRIS

Brand Name

IRIS-XP

Version/Model Number

IRIS

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K212412,K212412

Product Code

LHQ

Product Code Name

System, Telethermographic (Adjunctive Use)

Public Device Record Key

9d146c6a-6fa5-45df-b59a-5987305a24f7

Public Version Date

November 09, 2021

Public Version Number

1

DI Record Publish Date

November 01, 2021

Package DI Number

10191237000066

Quantity per Package

1

Contains DI Package

00191237000069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton