Duns Number:262207287
Device Description: The HFVI sensor is a disposable, pre-gelled 3-lead array.The HFVI sensor is to be usd with The HFVI sensor is a disposable, pre-gelled 3-lead array.The HFVI sensor is to be usd with the HFVI Pain Monitoring System and may be worn for a continous period of 24 hours in a hospital environment.
Catalog Number
-
Brand Name
HFVI SENSOR V1
Version/Model Number
V1
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
Yes
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
7b483267-6cd3-4d2f-84c3-5ed131809aa2
Public Version Date
February 11, 2019
Public Version Number
1
DI Record Publish Date
January 10, 2019
Package DI Number
03760232460221
Quantity per Package
10
Contains DI Package
03760232460238
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |