Trackit Sleepwalker 1301

GUDID 05060275450127

LIFELINES LIMITED

Polysomnograph

• Primary Device ID: 05060275450127
• NIH Device Record Key: e645308e-e04a-4e38-adff-41c334f23d4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trackit Sleepwalker
• Version Model Number: MK3 Standard
• Catalog Number: 1301
• Company DUNS: 237089235
• Company Name: LIFELINES LIMITED
• 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: 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: +441483224245
• Email: wayne.williams@llines.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060275450127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010460

FDA Product Code

• OLV: Standard Polysomnograph With Electroencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-18
• Device Publish Date: 2019-01-18

On-Brand Devices [Trackit Sleepwalker]

• 05060275450691: MK3 + SaO2 + BT Kit
• 05060275450684: MK3 + BT Kit
• 05060275450677: MK3 + SaO2 Kit
• 05060275450660: MK3 Standard Kit
• 05060275450158: MK3 + SaO2 + BT
• 05060275450141: MK3 + BT
• 05060275450134: MK3 + SaO2
• 05060275450127: MK3 Standard