Duns Number:938289980
Device Description: A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
Catalog Number
411008-000
Brand Name
EXTENSION LINE W/16GA MODIFIED NEEDLE
Version/Model Number
411008-000
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
DTR
Product Code Name
Heat-Exchanger, Cardiopulmonary Bypass
Public Device Record Key
dbbb7a52-634c-4bf7-b6e5-2d71f479bc9c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 09, 2015
Package DI Number
B0664110080007
Quantity per Package
75
Contains DI Package
B0664110080000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PARTIAL CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |