MPS Console Adapter, base mount

GUDID 20634624500253

QUEST MEDICAL INC

Cardiopulmonary bypass system heat exchanger, reusable

• Primary Device ID: 20634624500253
• NIH Device Record Key: c7a6bcd0-6fdd-405f-bf47-4c4c3101061b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MPS Console Adapter, base mount
• Version Model Number: 5001025
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20634624500253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953838

FDA Product Code

• DTR: Heat-Exchanger, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-10-10

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• 20634624101306 - Q2 IV Administration Set: 2022-12-14
• 20634624601257 - Q2 IV Administration Set: 2022-12-14
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• 20634624921102 - High-Flow 4-Way Stopcock: 2022-12-14