PACE 101H PACE 101H

GUDID 00836559008859

Single Chamber External Pacemaker

Oscor Inc.

External pacemaker, epicardial pacing

• Primary Device ID: 00836559008859
• NIH Device Record Key: c0ad0a1e-1c16-4a7d-aa9a-9afa8bf98ba2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACE 101H
• Version Model Number: PACE 101H
• Catalog Number: PACE 101H
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836559008859 [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: 2016-09-09

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