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
301011NS
Brand Name
Quickie Prime - 1/4" x 1/169"
Version/Model Number
301011NS
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K801402,K801402,K801402
Product Code
DTL
Product Code Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Public Device Record Key
42d602e8-0ce2-4195-a007-fa009d047fc6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 06, 2017
Package DI Number
B066301011NS3
Quantity per Package
250
Contains DI Package
B066301011NS1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bagged quantity
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |