Helix CSL500

GUDID 00817650020018

Heim LH Nkey chassis

HARMAR SUMMIT, LLC

Stairlift, chair

• Primary Device ID: 00817650020018
• NIH Device Record Key: e9d97a9f-4f49-43e3-b1f1-95f9f1f40e9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Helix
• Version Model Number: Heim LH
• 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	00817650020018 [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