Direct Supply

GUDID 80092237618727

DS SoundCare Plus - Prof.

COMPASS HEALTH BRANDS CORP.

Physical therapy ultrasound system

• Primary Device ID: 80092237618727
• NIH Device Record Key: 5f31e08d-d414-4011-ba64-0e416b8b2181
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Direct Supply
• Version Model Number: DS-ULTRSND
• Company DUNS: 827221698
• Company Name: COMPASS HEALTH BRANDS CORP.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: 440-572-1962
• Email: CustomerService@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00092237618721 [Primary]
GS1	80092237618727 [Package]; Contains: 00092237618721; Package: CA [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120217

FDA Product Code

• IMG: Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

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: 2016-10-12

On-Brand Devices [Direct Supply]

• 80092237618727: DS SoundCare Plus - Prof.
• 80092237618710: DS TENS 7000 2nd Generation
• 80092237618703: DS TENS 3000, Dual Channel,
• 80092237618697: DS InTENSity 10 Digital TENS
• 30092237618685: DS Electrode - Foil - 2x2 -
• 01092237618676: DS K120 Electrode, Poly Bag 2
• 10092237617813: DS EX4
• 10092237617806: DS CX4
• 00092237613573: DS Attendant Nebulizer
• 00092237613566: DS Attendant Aspirator
• 00815067079414: DS A-Series Bariatric Rollator
• 00815067079407: DS A-Series Folding Rollator