Duns Number:801895244
Device Description: Vantage ABI SystemContents: Two 10cm cuffs, two 12cm cuffs, four color-coded hoses; report Vantage ABI SystemContents: Two 10cm cuffs, two 12cm cuffs, four color-coded hoses; reporting software CD, USB memory stick, roll stand with basket, ABI report forms and built-in printer.
Catalog Number
-
Brand Name
Summit Doppler
Version/Model Number
VANMAX
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K103693
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
0f3346a8-4b57-4255-8b82-72ac285aa74e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 28, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |