CARDIOTRONIC

GUDID 04260451441043

ICON Non-invasive Hemodynamic Cardiometer

Osypka Medical GmbH

Impedance cardiac output unit Impedance cardiac output unit Impedance cardiac output unit Impedance cardiac output unit Impedance cardiac output unit Impedance cardiac output unit Impedance cardiac output unit Impedance cardiac output unit Impedance cardiac output unit Impedance cardiac output unit Impedance cardiac output unit Impedance cardiac output unit Impedance cardiac output unit Impedance cardiac output unit Impedance cardiac output unit

• Primary Device ID: 04260451441043
• NIH Device Record Key: 2163bc02-f1d9-4bf6-b390-4e7d5f46e2d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARDIOTRONIC
• Version Model Number: ICON
• Company DUNS: 317157048
• Company Name: Osypka Medical GmbH
• 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: false
• 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

Customer Support Contacts

• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net
• Phone: +1 858 454 0600
• Email: mail@cardiotronic.net

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260451441043 [Primary]

FDA Product Code

• DSB: Plethysmograph, Impedance

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: 2021-05-10
• Device Publish Date: 2021-04-30

On-Brand Devices [CARDIOTRONIC]

• 04260451441029: PACE 203 External Dual-Chamber Pacemaker
• 04260451441012: PACE 101 External Single-Chamber Pacemaker
• 04260451441067: PACE 203 External Dual-Chamber Pacemaker (with bipolar terminals)
• 04260451441050: PACE 101 External Single-Chamber Pacemaker (with bipolar terminals)
• 04260451441043: ICON Non-invasive Hemodynamic Cardiometer