MPS Back Up System, side crank

GUDID 20634624510153

MPS Back Up System, side crank, blood only.

QUEST MEDICAL INC

Cardiopulmonary bypass system heat exchanger, reusable

• Primary Device ID: 20634624510153
• NIH Device Record Key: 3ea5ccc4-4a8a-4783-afb6-13f1bf24c30f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MPS Back Up System, side crank
• Version Model Number: 5001015
• 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

Customer Support Contacts

• Phone: 1-800-627-0226
• Email: Custserv@questmedical.com
• Phone: 1-800-627-0226
• Email: Custserv@questmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	20634624510153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002366

FDA Product Code

• DWF: Catheter, Cannula And Tubing, Vascular, 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: 2016-10-12

On-Brand Devices [MPS Back Up System, side crank]

• 20634624510177: MPS Back Up System, side crank, crystalloid only
• 20634624510153: MPS Back Up System, side crank, blood only.