RetroGuard Arterial Safety Valve 4007100

GUDID 20634624471003

QUEST MEDICAL INC

Cardiopulmonary bypass system valve, unidirectional flow/pressure control Cardiopulmonary bypass system valve, unidirectional flow/pressure control

• Primary Device ID: 20634624471003
• NIH Device Record Key: fd65500c-3d6b-4f88-8cbc-db6b199c9778
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RetroGuard Arterial Safety Valve
• Version Model Number: 4007100
• Catalog Number: 4007100
• Company DUNS: 041810693
• Company Name: QUEST MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634624471009 [Primary]
GS1	20634624471003 [Package]; Contains: 00634624471009; Package: Shipper [25 Units]; In Commercial Distribution

FDA Product Code

• MJJ: Cpb Check Valve, Retrograde Flow, In-Line

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-03

On-Brand Devices [RetroGuard Arterial Safety Valve]

• 20634624471003: 4007100
• 20634624472000: 4007200