Duns Number:595138793
Device Description: CRITIKIT(TM) SP4500 consists of a banded cooling coil connected via a 40" pressure tubing CRITIKIT(TM) SP4500 consists of a banded cooling coil connected via a 40" pressure tubing and a 2-way check valve. It has a 10ml control syringe and a separate packed 3-way stopcock and 2 protective caps.
Catalog Number
680000
Brand Name
CRITIKIT(TM) SP4500
Version/Model Number
680000
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
e7aa6ddf-1738-447a-b979-36b8bc365958
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
50886333600002
Quantity per Package
8
Contains DI Package
00886333600007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tray
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 392 |