Roscoe Medical

GUDID 30092237620817

DreamEasy 2 Full Face CPAP Mask, Medium

COMPASS HEALTH BRANDS CORP.

CPAP/BPAP face mask, reusable

• Primary Device ID: 30092237620817
• NIH Device Record Key: 97287fdc-8bc8-4db7-a0fa-be286ca1ceb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Roscoe Medical
• Version Model Number: CPM-DEF2M
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8003767263
• 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	00092237620816 [Primary]
GS1	30092237620817 [Package]; Contains: 00092237620816; Package: CA [50 Units]; In Commercial Distribution

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-24
• Device Publish Date: 2018-07-24

On-Brand Devices [Roscoe Medical]

• 30092237620831: DreamEasy 2 Full Face CPAP Mask, Starter Kit
• 30092237620824: DreamEasy 2 Full Face CPAP Mask, Large
• 30092237620817: DreamEasy 2 Full Face CPAP Mask, Medium
• 30092237620800: DreamEasy 2 Full Face CPAP Mask, Small
• 30092237620732: Dinosaur Nebulizer Compressor with Reusable and Disposable Neb Kits and Carry Bag
• 30092237620725: Bunny Nebulizer Compressor System with Reusable and Disposable Neb Kits and Carry Bag
• 00092237620663: Dog Nebulizer Compressor with Carry Bag
• 00092237619834: Heavy duty aspirator
• 00092237619827: 50 PSI Aerosol Compressor
• 00092237619810: Pediatric Hippo Nebulizer Compressor
• 30092237619804: Roscoe Rite-Neb 4 Nebulizer Compressor with Disposable Neb Kit
• 00092237619711: ZZZ Mask Full Face Small w/ Headgear
• 00092237619704: ZZZ Mask Full Face Medium with Headgear
• 00092237619698: ZZZ Mask Full Face, Large w/ Headgear
• 00092237619575: 6" Silicone Tubing
• 00092237619537: 4" Silicone Tubing
• 00092237619506: Silicone Tubing for ROS-COMP
• 00092237619490: Silicone Tubing for Suction 4"
• 00092237616147: Final Bacteria Filter
• 00092237616130: Suction Filter 1/4-3/8
• 00092237616123: Suction Filter, 1/4
• 00092237616116: VA Final Bacteria Filter
• 00092237615430: Newport Vent and LP10 Intake Filter
• 00092237614525: Suction Filter
• 00092237614419: Empty Humidifier Jar
• 00092237614358: Intake Filter Silencer
• 00092237614341: Compressor Intake Filter
• 50092237614209: Roscoe Neb kit incl Supply
• 50092237614193: Neb kit with Pediatric Mask
• 50092237614186: Neb kit with Adult Mask
• 00092237613948: Intake Bacteria Filter
• 60092237613926: SierraNeb 2 Neb Compressor
• 00092237613870: Pediatric Frog Nebulizer Compressor
• 00092237613863: Pediatric Dog Nebulizer Compressor
• 00092237613856: Dinosaur Nebulizer Compressor
• 00092237613849: Bunny Nebulizer Compressor
• 30092237607054: Replacement LAL Mattress
• 80092237605291: Shadow Nasal Pillows Mask (XS/
• 90092237605045: Compressor Intake Filter
• 80092237604874: DreamEasy Nasal CPAP Mask Starter Kit
• 80092237604867: DreamEasy Nasal Mask w/ HG,
• 80092237604850: DreamEasy Nasal Mask w/ HG,
• 80092237604843: DreamEasy Nasal Mask w/ HG,
• 80092237604836: DreamEasy Full Face Mask w/
• 80092237604829: DreamEasy Full Face Mask w/
• 80092237604812: DreamEasy Full Face Mask with
• 10092237603816: Collection Jar 800cc with Float Top
• 90092237603492: Compressor intake filter
• 20092237603387: Roscoe Portable Suction
• 20092237603370: Roscoe Suction Machine