Duns Number:241235050
Device Description: Rapid Relief Instant Cold Pack (single use)
Catalog Number
-
Brand Name
Rapid Relief Cold
Version/Model Number
31259
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
Yes
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
IMD
Product Code Name
Pack, Hot Or Cold, Disposable
Public Device Record Key
68246358-b660-49d3-a450-505f885ad69a
Public Version Date
March 22, 2021
Public Version Number
2
DI Record Publish Date
February 08, 2021
Package DI Number
16431731259244
Quantity per Package
24
Contains DI Package
00064317312591
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipper case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |