Duns Number:595138793
Device Description: Injectate delivery system includes a sensor housing with two-way check valve, a cooling co Injectate delivery system includes a sensor housing with two-way check valve, a cooling coil, a IV administration set, a 10 cc control syringe, 3-way stopcock and two male luer lock protective covers.
Catalog Number
680002
Brand Name
CRITIKIT(TM) SP4572
Version/Model Number
680002
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
-
Product Code
KRB
Product Code Name
Probe, Thermodilution
Public Device Record Key
53db0a43-23c0-4c0f-a2a9-e197a60ca3ef
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
50886333600026
Quantity per Package
50
Contains DI Package
00886333600021
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 392 |