Duns Number:006261481
Device Description: SENSOR ARRAY VEST CITVST0002M US
Catalog Number
-
Brand Name
CardioInsight™
Version/Model Number
CITVST0002M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 04, 2019
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
Yes
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
K162440
Product Code
DQK
Product Code Name
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Public Device Record Key
177ac703-fab2-457b-9274-f1e3c7d9f1c1
Public Version Date
June 13, 2019
Public Version Number
4
DI Record Publish Date
February 02, 2017
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |