Duns Number:057028415
Device Description: A device to continuously monitor peripheral IVs for the early detection of IV infiltration A device to continuously monitor peripheral IVs for the early detection of IV infiltration and extravasation events
Catalog Number
00814088020009
Brand Name
ivWatch Patient Monitor
Version/Model Number
Model 400
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
-
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
PMS
Product Code Name
Peripheral Intravenous (Piv) Infiltration Monitor
Public Device Record Key
39e67d5f-33c3-4185-8235-7dbbc5a2fc81
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 14, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |