Breas iSleep 20+ system 206000

GUDID 07321822060168

Ventilator Non-continuous (Respirator)

Breas Medical AB

Home CPAP unit

• Primary Device ID: 07321822060168
• NIH Device Record Key: 7e5e6162-1269-42d2-bed9-0d9db52b800b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breas iSleep 20+ system
• Version Model Number: US
• Catalog Number: 206000
• Company DUNS: 357007657
• Company Name: Breas Medical AB
• 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: 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: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com
• Phone: +4631868860
• Email: techsupport@breas.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07321822060007 [Primary]
GS1	07321822060168 [Package]; Contains: 07321822060007; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061057

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

Devices Manufactured by Breas Medical AB

• 07321820021857 - Vivo 50, Vivo 65, Vivo 45 LS: 2022-06-27 Memory Card Reader
• 07321820035229 - Vivo 45 LS: 2022-06-27 Power Cord US
• 07321820044269 - Vivo Series: 2022-06-27 Swivel Leakage Port
• 07321820045594 - Vivo 50, VIvo 65: 2022-06-27 Click-On Battery
• 07321820048861 - Vivo 50, Vivo 65: 2022-06-27 USB Cable A-B
• 07321820048915 - Vivo 50: 2022-06-27 Nurse Call Cable NO
• 07321820048922 - Vivo 50: 2022-06-27 Nurse Call Cable NC
• 07321820048939 - Vivo 50: 2022-06-27 Nurse Call Cable NO, 10 KOhm