MPS2 console

GUDID 20634624522262

MPS2 Console, 220 volt, 60 Hz

QUEST MEDICAL INC

Cardiopulmonary bypass system heat exchanger, reusable Cardiopulmonary bypass system heat exchanger, reusable

• Primary Device ID: 20634624522262
• NIH Device Record Key: 6687d2b6-4157-4c98-b9aa-c99b94788c0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MPS2 console
• Version Model Number: 5202260
• 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	20634624522262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041979

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: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-08-31

On-Brand Devices [MPS2 console]

• 20634624524501: MPS2 console, 240 volt, 50Hz
• 20634624522262: MPS2 Console, 220 volt, 60 Hz
• 20634624521265: Myocardial Protection System (MPS) 2 console