Duns Number:346332666
Device Description: Novii Patch
Catalog Number
-
Brand Name
Novii
Version/Model Number
107-PT-004
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"
-
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
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
7389174f-b800-4197-8d98-b2007d406e8f
Public Version Date
September 25, 2018
Public Version Number
4
DI Record Publish Date
September 12, 2016
Package DI Number
35060433670078
Quantity per Package
5
Contains DI Package
25060433670071
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |