Duns Number:938289980
Device Description: A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass sy A sterile 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
342334-000
Brand Name
CONN, Y 3/8" X 3/8" X 1/2" W/LUER
Version/Model Number
342334-000
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
KRI
Product Code Name
Accessory Equipment, Cardiopulmonary Bypass
Public Device Record Key
919dcd58-5439-4641-b7ac-febd59cc337d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 06, 2015
Package DI Number
B0663423340005
Quantity per Package
100
Contains DI Package
B0663423340000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
OUTER SHIPPER
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |