Duns Number:687879726
Device Description: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, The AVSM2 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 AVSM2 is suitable for continuous operation.
Catalog Number
V10D-3XBCRU
Brand Name
Direct Supply
Version/Model Number
AVSM2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 25, 2018
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
b02196b7-35ed-458c-93a5-b0c9a3c3dacc
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
January 23, 2018
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 |