Duns Number:117310689
Device Description: Family Wellness Hot-Cold Reusable Gel Pack-Direct to Skin, 1 Count
Catalog Number
86-914
Brand Name
Family Wellness
Version/Model Number
0999010
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
-
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
f5efc233-b856-49cd-9b48-054023ce5512
Public Version Date
May 04, 2020
Public Version Number
2
DI Record Publish Date
January 27, 2020
Package DI Number
10032251578110
Quantity per Package
24
Contains DI Package
30032251578114
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |