Breas iSleep 20+ system 206000

GUDID 07321822060168

Ventilator Non-continuous (Respirator)

Breas Medical AB

Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit 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