HUMAN DESIGN MEDICAL HD60-1005

GUDID 00859477004017

Ventilator, Non Continuous Respirator

BREAS MEDICAL, INC.

Home CPAP unit

• Primary Device ID: 00859477004017
• NIH Device Record Key: 825bd3f3-1c9b-4588-b731-d661f5ffa45a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HUMAN DESIGN MEDICAL
• Version Model Number: US
• Catalog Number: HD60-1005
• Company DUNS: 079296736
• Company Name: BREAS MEDICAL, INC.
• 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: 855-436-8729
• Email: hdmsupport@hdmusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859477004017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121374

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: 4
• Public Version Date: 2019-04-19
• Device Publish Date: 2016-07-14

On-Brand Devices [HUMAN DESIGN MEDICAL]

• 00859477004161: Ventilator, Non Continuous Respirator with Battery Source
• 00859477004123: Ventilator, Non Continuous Respirator
• 00859477004116: Battery Source for Ventilator, Non Continuous Respirator
• 00859477004017: Ventilator, Non Continuous Respirator
• 00859477004000: Ventilator, Non Continuous Respirator with Battery Source