Duns Number:938289980
Device Description: A plastic device designed to join two or more tubes of a cardiopulmonary bypass system cir A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
Catalog Number
C445B
Brand Name
CONNECTOR, Y 1/2" X 3/8" X 3/8" W/LUER
Version/Model Number
C445B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KOC
Product Code Name
Accessories, Blood Circuit, Hemodialysis
Public Device Record Key
146ee953-ab46-4ea0-bcc6-d0a028b2758a
Public Version Date
March 09, 2022
Public Version Number
3
DI Record Publish Date
September 14, 2015
Package DI Number
B066C445B5
Quantity per Package
1000
Contains DI Package
B066C445B1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |