SleepmateQDC Viasys Sum Belt Kit (2) 819100-100

GUDID 05707480044429

Ref. 1961

Ambu A/S

Polysomnograph

• Primary Device ID: 05707480044429
• NIH Device Record Key: 69b6ff6e-430a-4cfc-b762-36a5f8d3d52b
• Commercial Distribution Discontinuation: 2018-06-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SleepmateQDC Viasys Sum Belt Kit (2)
• Version Model Number: 819100-100
• Catalog Number: 819100-100
• Company DUNS: 305682023
• Company Name: Ambu A/S
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480044429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903300

FDA Product Code

• BZQ: Monitor, breathing frequency

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

Devices Manufactured by Ambu A/S

• 05707480159246 - Ambu® SureSight® Blade: 2024-12-23 Video Laryngoscope Blade
• 05707480159277 - Ambu® SureSight® Blade: 2024-12-23 Video Laryngoscope Blade
• 05707480159314 - Ambu® SureSight® Blade: 2024-12-23 Video Laryngoscope Blade
• 05707480159338 - Ambu® SureSight® Blade: 2024-12-23 Video Laryngoscope Blade
• 05707480159369 - Ambu® SureSight® Blade: 2024-12-23 Video Laryngoscope Blade
• 05707480159390 - Ambu® SureSight® Connect: 2024-12-23 Reusable Video Laryngoscope Adapter
• 05060038512864 - Ambu WhiteSensor 4535MECG Electrodes: 2024-12-16 Ambu White Sensor 4535M Electrode with wet gel and foam backing. Center snap and PVC free For short-term monitoring Packing: 60
• 05707480164486 - Ambu® aScope™ 5 Cysto HD: 2024-11-14 Flexible Cystoscope, Reverse Deflection