Osypka Medical

GUDID 04260451441173

PSA 200 Pacing System Analyzer

Osypka Medical GmbH

External pacemaker, epicardial pacing

• Primary Device ID: 04260451441173
• NIH Device Record Key: 780129a1-9872-4b17-b7f5-987090f9c078
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osypka Medical
• Version Model Number: PSA 200
• 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	04260451441173 [Primary]

FDA Product Code

• DTE: Pulse-Generator, Pacemaker, External

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

Devices Manufactured by Osypka Medical GmbH

• 04260451441043 - CARDIOTRONIC: 2021-05-10 ICON Non-invasive Hemodynamic Cardiometer
• 04260451441050 - CARDIOTRONIC: 2021-05-10 PACE 101 External Single-Chamber Pacemaker (with bipolar terminals)
• 04260451441067 - CARDIOTRONIC: 2021-05-10 PACE 203 External Dual-Chamber Pacemaker (with bipolar terminals)
• 04260451441173 - Osypka Medical: 2021-05-10PSA 200 Pacing System Analyzer
• 04260451441173 - Osypka Medical: 2021-05-10 PSA 200 Pacing System Analyzer
• 04260451441012 - CARDIOTRONIC: 2018-10-05 PACE 101 External Single-Chamber Pacemaker
• 04260451441029 - CARDIOTRONIC: 2018-10-05 PACE 203 External Dual-Chamber Pacemaker