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 cardiopulmonary bypass procedure by connecting and administration line. 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
411009-000
Brand Name
Goodwin Heart Line
Version/Model Number
411009-000
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"
Yes
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
K802545,K802545
Product Code
DTR
Product Code Name
Heat-Exchanger, Cardiopulmonary Bypass
Public Device Record Key
96c989ef-db06-4114-b643-fabf27d1677b
Public Version Date
March 08, 2019
Public Version Number
1
DI Record Publish Date
February 05, 2019
Package DI Number
B0664110090003
Quantity per Package
10
Contains DI Package
B0664110090000
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 |