Duns Number:121788819
Device Description: Nova Blanket, Lower BodyNova Blanket, Lower Body, 30"W x 51"L, IND PKG, 25 EA/CS
Catalog Number
-
Brand Name
Nova
Version/Model Number
AW5100-300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K203085,K203085
Product Code
DWJ
Product Code Name
System, Thermal Regulating
Public Device Record Key
6f148201-9191-484a-9188-5d07bb642f0f
Public Version Date
July 15, 2021
Public Version Number
1
DI Record Publish Date
July 07, 2021
Package DI Number
50612899006497
Quantity per Package
25
Contains DI Package
00612899006492
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |