QUICKIE PRIME - 1/4" X 3/32"

Basic Information

• Brand Name: QUICKIE PRIME - 1/4" X 3/32"
• Primary DI: B066301012NS1
• Version / Model: 301012NS
• Catalog Number: 301012NS
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2015-10-09
• Public Version: 3
• Public Version Date: 2023-07-14
• Public Version Status: Update
• Public Device Record Key: b229b593-2686-475d-88e3-d1359e197715

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	870.4290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47889	Cardiopulmonary bypass system priming set	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B066301012NS1	HIBCC
Unit of Use	B66301012NS0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K801402	000