Duns Number:096372255
Device Description: Cold Therapy Blanket
Catalog Number
-
Brand Name
DeRoyal
Version/Model Number
301C35
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILO
Product Code Name
Pack, hot or cold, water circulating
Public Device Record Key
7e08a1d4-bdc9-415b-8a5f-d388ad4fa268
Public Version Date
August 10, 2021
Public Version Number
3
DI Record Publish Date
September 12, 2016
Package DI Number
50749756876372
Quantity per Package
10
Contains DI Package
00749756876377
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7041 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
| U | Unclassified | 3 |