CARDIOTRONIC

GUDID 04260451441012

PACE 101 External Single-Chamber Pacemaker

Osypka Medical GmbH

External pacemaker, epicardial pacing

• Primary Device ID: 04260451441012
• NIH Device Record Key: 4d44fbf0-6a32-412a-9170-004fd2ffcc1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARDIOTRONIC
• Version Model Number: PACE 101
• 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
• 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
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260451441012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033130

FDA Product Code

• DTE: Pulse-Generator, Pacemaker, External

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: 2018-10-05
• Device Publish Date: 2016-09-13

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