Zmachine

GUDID B5663000010

General Sleep

Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system

• Primary Device ID: B5663000010
• NIH Device Record Key: 5fc78ddc-6f20-43eb-b29c-945d67994fb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zmachine
• Version Model Number: Synergy
• Company DUNS: 860092022
• Company Name: General Sleep
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com
• Phone: (216) 289-2331
• Email: support@generalsleep.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B5663000010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172986

FDA Product Code

• MNR: Ventilatory Effort Recorder

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-01

On-Brand Devices [Zmachine]

• B5663000010: Synergy
• B5662000010: Insight/Insight+