Breas iSleep 20i system 207000

GUDID 07321822070167

Ventilator Non-continuous (Respirator)

Breas Medical AB

Home CPAP unit

• Primary Device ID: 07321822070167
• NIH Device Record Key: 6adde063-2d34-4293-a816-f5259869e7d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breas iSleep 20i system
• Version Model Number: US
• Catalog Number: 207000
• 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	07321822070006 [Primary]
GS1	07321822070167 [Package]; Contains: 07321822070006; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063476

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

• 07321820044658 - Vivo 1/2, Vivo 3: 2025-05-28 Circuit: Single limb, 22 mm. Single, patient multiple use
• 07321820067121 - Vivo 1/2, Vivo 3: 2025-05-28 Circuit: Single limb 15 mm. Single patient multiple use
• 07321820070060 - Vivo 1/2, Vivo 3: 2025-05-28 Y Cable
• 07321820070145 - Vivo 1/2, Vivo 3: 2025-05-28 Protective Cover
• 07321820072026 - Vivo 1/2, Vivo 3: 2025-05-28 Air Inlet Filter, white (5pcs)
• 07321820072033 - Vivo 1/2, Vivo 3: 2025-05-28 Air Inlet Filter, grey (5pcs)
• 07321820073801 - Vivo 1/2, Vivo 3: 2025-05-28 Lightweight Mobility Bag
• 07321820084265 - Vivo 1/2, Vivo 3: 2025-05-28 Circuit: Single limb 22 mm. Single patient multiple use (30-pack)