Duns Number:134139174
Device Description: CV THERMISTOR KIT 5 PACK
Catalog Number
VLVCVT5
Brand Name
VOLUMEVIEW
Version/Model Number
VLVCVT5
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
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
K100739,K100739
Product Code
KRB
Product Code Name
PROBE, THERMODILUTION
Public Device Record Key
5382bc53-25e9-4507-ad78-e75bb11b86b9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 03, 2016
Package DI Number
50690103183905
Quantity per Package
5
Contains DI Package
00690103183900
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |