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 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.