MiniGuard Arterial Safety Valve

Basic Information

• Brand Name: MiniGuard Arterial Safety Valve
• Primary DI: 10634624481005
• Version / Model: 4008100
• Catalog Number: 4008100
• Company Name: QUEST MEDICAL INC
• Labeler DUNS: 041810693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-18
• Public Version: 1
• Public Version Date: 2019-02-18
• Public Version Status: New
• Public Device Record Key: 21bd3b33-d6ea-414e-82b9-b08fa134c4a0

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
MJJ	Cpb Check Valve, Retrograde Flow, In-Line	Cardiovascular	870.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17581	Cardiopulmonary bypass system valve, unidirectional flow/pressure control	A sterile, mechanical regulator used in a cardiopulmonary bypass system, particularly systems employing centrifugal pumps during open-heart surgery. It typically provides unidirectional flow to prevent inadvertent backflow of blood and air into the heart, and/or controls the pressure within the system (e.g., maintains gentle suction to prevent line collapse during left ventricular venting, or controls the vacuum from suctioning of the heart or the surgical field). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20634624481002	GS1	Box	25	In Commercial Distribution
Primary	10634624481005	GS1

Premarket Submissions

Submission Number	Supplement Number
K182442	000