Catalog Number

-

Brand Name

Infrared Heating device

Version/Model Number

PM-750

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 21, 2021

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Public Device Record Key

047c3b2a-c345-4211-b494-476235fc886a

Public Version Date

April 25, 2022

Public Version Number

6

DI Record Publish Date

October 21, 2016

Package DI Number

10018509800851

Quantity per Package

30

Contains DI Package

00185098000854

Package Discontinue Date

October 21, 2021

Package Status

Not in Commercial Distribution

Package Type

-