MPS

GUDID 20634624501113

MPS Water Circuit Adapter

QUEST MEDICAL INC

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• Primary Device ID: 20634624501113
• NIH Device Record Key: 7b071142-3177-49d0-8cfd-52029f563b1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MPS
• Version Model Number: 5001110
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20634624501113 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-16

On-Brand Devices [MPS]

• 20634624551170: MPS® Retrograde extension line without transducer
• 20634624551132: MPS® Pressure Line w/transducer
• 20634624551125: MPS® Retrograde extension pressure line w/Y-set
• 20634624551118: MPS® Retrograde external pressure line w/pressure transducer
• 20634624521128: MPS® Delivery Set with 6 ft. delivery tubing
• 20634624501182: MPS® Antegrade/Retrograde Y-Set
• 20634624501168: MPS® Extension Line (10 ft. x 3/16 in. ID)
• 20634624501151: MPS® Additive Agent Cassette
• 20634624501144: MPS® Arrest Agent Cassette
• 20634624501137: MPS Delivery Set with arrest agent or additive cassettes, 183 cm extension line
• 20634624501120: MPS® Delivery Set w/arrest agent and additive cassettes, heat exchanger & 10 ft. delivery tubin
• 20634624501113: MPS Water Circuit Adapter
• 20634624500116: Dual Spike Crystalloid Y Adapter