Duns Number:961027315
Device Description: Hot Pack Instant
Catalog Number
V11450-040B
Brand Name
NOVAPLUS
Version/Model Number
V11450-040B
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)
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
a642b7b8-ee60-4f38-90d6-946516f878d2
Public Version Date
April 22, 2019
Public Version Number
1
DI Record Publish Date
April 12, 2019
Package DI Number
50885380167193
Quantity per Package
10
Contains DI Package
10885380167195
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |