Duns Number:249008772
Device Description: Hot & Cold Therapy Eye Mask with ThermaBeadsTM for therelief of symptoms associated with B Hot & Cold Therapy Eye Mask with ThermaBeadsTM for therelief of symptoms associated with Blepharitis, Dry Eye Disease, MeibomianGland Disease (MGD), Styes and Chalazia as well as headaches, sinuspressure, tension, swelling and puffiness.
Catalog Number
0890
Brand Name
I-RELIEF Hot and Cold Therapy Eye Mask
Version/Model Number
0890
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"
Yes
For Single-Use
Yes
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
-
Product Code
IME
Product Code Name
Pack, hot or cold, reusable
Public Device Record Key
d5aca48e-2e10-4d29-b9f6-25f093c551e4
Public Version Date
October 05, 2022
Public Version Number
3
DI Record Publish Date
June 18, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |