Duns Number:687879726
Device Description: The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, di The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic, and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.
Catalog Number
V10M-3PXCRU
Brand Name
Patient Monitor V10
Version/Model Number
V10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
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
K170497
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
5dbe8f88-5e73-4839-aaa8-4cc4eae5affe
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
February 07, 2019
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. | 33 |