Quantum SuperPAC Cardioplegia Tubing Set 1/4

GUDID 18051160302793

SPECTRUM MEDICAL SRL

Cardioplegia solution administration kit

• Primary Device ID: 18051160302793
• NIH Device Record Key: d81b1314-1ed4-46d2-925b-dcde7e96c64e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum SuperPAC Cardioplegia Tubing Set 1/4
• Version Model Number: CGSP7-B0
• Company DUNS: 436188505
• Company Name: SPECTRUM MEDICAL SRL
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18051160302793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213540

FDA Product Code

• DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-12
• Device Publish Date: 2024-07-04

On-Brand Devices [Quantum SuperPAC Cardioplegia Tubing Set 1/4]

• 18051160302793: CGSP7-B0
• 18051160302786: CGSP6-B0