HELIOS

GUDID 00836559006640

Oscor Inc.

Atrial cardioversion system catheter

• Primary Device ID: 00836559006640
• NIH Device Record Key: c820c664-4f70-4a2c-9143-fb3a6a3e31a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELIOS
• Version Model Number: H05110U
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836559006640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072770

FDA Product Code

• LDF: Electrode, Pacemaker, Temporary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-07
• Device Publish Date: 2015-10-16

On-Brand Devices [HELIOS]

• 00885672001872: HRHCK05110S
• 00885672001865: HRHCK05110U
• 00885672001537: H05RH110S
• 00885672001520: H05RH110U
• 00836559007265: HK05110U
• 00836559007258: HK05110S
• 00836559006640: H05110U
• 00836559006633: H05110S