Helix CSL500

GUDID 00817650020001

Heim RH Nkey chassis

HARMAR SUMMIT, LLC

Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair Stairlift, chair

• Primary Device ID: 00817650020001
• NIH Device Record Key: bf1667f1-f7ec-45f4-9fc1-723f3b729658
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Helix
• Version Model Number: Heim RH
• Catalog Number: CSL500
• Company DUNS: 144008062
• Company Name: HARMAR SUMMIT, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com
• Phone: +1(800)833-0478
• Email: quality_team@harmar.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817650020001 [Primary]

FDA Product Code

• PCD: Powered stairway chair lift

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Helix]

• 00817650020049: Helix 3 LH NKEY Indoor chassis
• 00817650020025: Helix 3 RH NKEY Indoor chassis
• 00817650020018: Heim LH Nkey chassis
• 00817650020001: Heim RH Nkey chassis
• 00817650023040: Helix 4 Chassis LH IN
• 00817650023033: Helix 4 Chassis RH IN
• 00817650023064: Helix 4 Chassis RH OUT
• 00817650023057: Helix 4 Chassis LH OUT
• 00817650026034: Helix 4 Chassis LH IN OSG
• 00817650026027: Helix 4 Chassis RH IN OSG
• 00817650026010: Helix 4 Chassis LH OUT OSG
• 00817650026003: Helix 4 Chassis RH OUT OSG