PRESSURE GAUGE ISOLATOR KIT

Basic Information

• Brand Name: PRESSURE GAUGE ISOLATOR KIT
• Primary DI: B0663014000000
• Version / Model: 301400-000
• Catalog Number: 301400-000
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-09
• Public Version: 3
• Public Version Date: 2023-07-07
• Public Version Status: Update
• Public Device Record Key: 81262ce7-628c-4254-8d2e-e3a8494ae5e3

Device Description

A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). 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: Yes
• 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
DXS	Gauge, Pressure, Coronary, Cardiopulmonary Bypass	Cardiovascular	870.4310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33309	Cardiopulmonary bypass system filter, arterial blood line	A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B0663014000007	HIBCC	PARTIAL CASE	75	In Commercial Distribution
Primary	B0663014000000	HIBCC
Package	B0663014000006	HIBCC	PARTIAL CASE	50	In Commercial Distribution
Package	B0663014000005	HIBCC	CASE	100	In Commercial Distribution
Package	B0663014000003	HIBCC	INNER CARTON	25	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K912045	000