Duns Number:112164780
Device Description: Instant Cold Pack Non-Sweat 6x9in Large Latex Free
Catalog Number
V11440-012
Brand Name
NOVAPLUS
Version/Model Number
V11440-012
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
IMD
Product Code Name
PACK, HOT OR COLD, DISPOSABLE
Public Device Record Key
e7debb38-4933-4122-9b52-27594054f228
Public Version Date
May 20, 2019
Public Version Number
1
DI Record Publish Date
May 10, 2019
Package DI Number
50885380057470
Quantity per Package
4
Contains DI Package
20885380057479
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 | 81 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 111 |