Duns Number:938289980
Device Description: A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of primin A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device.
Catalog Number
301132-000
Brand Name
Quickie Prime - 32" w/2 Spikes
Version/Model Number
301132-000
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
K801402,K801402
Product Code
DTL
Product Code Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Public Device Record Key
5093ec5b-ad82-4d3d-9a55-5ce333f41af6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 26, 2016
Package DI Number
B0663011320006
Quantity per Package
25
Contains DI Package
B0663011320000
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 |