PACE 203H PACE 203H LOANER

GUDID 00885672005467

Dual Chamber Temporary External Pacemaker

Oscor Inc.

External pacemaker, epicardial pacing

• Primary Device ID: 00885672005467
• NIH Device Record Key: 149f72c0-b0ac-4fb6-b823-741cabbfe8ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACE 203H
• Version Model Number: PACE 203H LOANER
• Catalog Number: PACE 203H LOANER
• Company DUNS: 101835833
• Company Name: Oscor Inc.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672005467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020896

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: 2016-09-17

On-Brand Devices [PACE 203H]

• 00885672005467: Dual Chamber Temporary External Pacemaker
• 00836559008866: Dual Chamber Temporary External Pacemaker