MPS 3 ND Console

GUDID 20634624531004

QUEST MEDICAL INC

Cardiopulmonary bypass system heat exchanger, reusable

• Primary Device ID: 20634624531004
• NIH Device Record Key: eaa12901-f96a-46b3-adc7-7e58b5dca4de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MPS 3 ND Console
• Version Model Number: 5301000ND
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	20634624531004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201984

FDA Product Code

• DTR: Heat-Exchanger, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-15
• Device Publish Date: 2021-02-05

Devices Manufactured by QUEST MEDICAL INC

• 20634624530380 - MPS 3 ISO Medical Air Hose Kit: 2023-10-24
• 20634624530397 - MPS 3 Drug Pump Cover: 2023-04-03
• 20634624101153 - Q2 IV Administration Set: 2022-12-14
• 20634624101252 - Q2 IV Administration Set: 2022-12-14
• 20634624101306 - Q2 IV Administration Set: 2022-12-14
• 20634624601257 - Q2 IV Administration Set: 2022-12-14
• 20634624921096 - High-Flow 4-Way Stopcock: 2022-12-14
• 20634624921102 - High-Flow 4-Way Stopcock: 2022-12-14