MPS Hypothermic Reservoir

GUDID 20634624510016

QUEST MEDICAL INC

Cardiopulmonary bypass system heat exchanger, reusable

• Primary Device ID: 20634624510016
• NIH Device Record Key: 07175dfe-0821-46ee-87af-9c9badadd0dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MPS Hypothermic Reservoir
• Version Model Number: 5001001
• 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	20634624510016 [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

On-Brand Devices [MPS Hypothermic Reservoir]

• 20634624510016: 5001001
• 20634624510085: 5001001G