1/2" CORONARY PERFUSION PLUG

Basic Information

• Brand Name: 1/2" CORONARY PERFUSION PLUG
• Primary DI: B0663010940000
• Version / Model: 301094-000
• Catalog Number: 301094-000
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-09
• Public Version: 3
• Public Version Date: 2023-06-30
• Public Version Status: Update
• Public Device Record Key: e20b9fb9-f17b-4635-9a1e-dce17ea17d0b
• Distribution End Date: 2023-06-29

Device Description

1/2 TUBING TO FIT OVER THE CORONARY PERFUSION OUTLET PORT OF AN OXYGENATOR, TO SECURELY SEAL OFF THE PORT, THUS REDUCING THE POSSIBLITY OF THE PORT BEING INADVERTENTLY OPENED DUTING THE HEMOPERFUSION PROCEEDURE.

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
35375	Stopcock	A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B0663010940007	HIBCC	PARTIAL CASE	75	Not in Commercial Distribution	2023-06-29
Primary	B0663010940000	HIBCC
Package	B0663010940006	HIBCC	PARTIAL CASE	50	Not in Commercial Distribution	2023-06-29
Package	B0663010940005	HIBCC	CASE	100	Not in Commercial Distribution	2023-06-29
Package	B0663010940003	HIBCC	INNER CARTON	25	Not in Commercial Distribution	2023-06-29

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K801399	000