Cardiac Function Laboratory CDL001

GUDID 08717953256645

Inca PV loop system for the measurement of cardiac function and performance.

CD Leycom

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• Primary Device ID: 08717953256645
• NIH Device Record Key: 9b731f6e-c3af-46ce-8e51-51a0495c568c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiac Function Laboratory
• Version Model Number: CFL-M Inca
• Catalog Number: CDL001
• Company DUNS: 414947457
• Company Name: CD Leycom
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717953256645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003020

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-28
• Device Publish Date: 2023-09-20

Devices Manufactured by CD Leycom

• 08717953256645 - Cardiac Function Laboratory: 2023-09-28Inca PV loop system for the measurement of cardiac function and performance.
• 08717953256645 - Cardiac Function Laboratory: 2023-09-28 Inca PV loop system for the measurement of cardiac function and performance.
• 08719327737309 - 4 Fr PV Catheter: 2023-09-28 4 French PV Loop catheter with 6 mm electrode spacing
• 08719327737316 - 4 Fr PV Catheter: 2023-09-28 4 Fr PV Loop catheter with 10 mm electrode spacing
• 08719327737323 - 7 Fr PV-Catheter: 2023-09-28 7 French PV Loop Catheter with 8mm electrode spacing
• 08719327737330 - 7 Fr PV-Catheter: 2023-09-28 7 Fr PV Loop catheter with 10 mm electrode spacing
• 08719327737347 - 7 Fr PV-Catheter: 2023-09-28 7 Fr PV-Loop catheter with 12 mm electrode spacing