Duns Number:687879726
Device Description: The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure(NIB The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure(NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation(SpO2), pulse rate (PR) and temperature (TEMP) 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 V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement.
Catalog Number
AVSM3SNF-3XBNEU
Brand Name
Direct Supply
Version/Model Number
AVSM3
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
K200434
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
ccfb6d32-3619-410d-a679-4172f81b7c7d
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
June 18, 2021
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 |