Hybrid HYB513

GUDID 50833224000175

Hybrid Cushion- MD

Innomed Technologies Inc

CPAP/BPAP oral mask

• Primary Device ID: 50833224000175
• NIH Device Record Key: 4f7eef69-651f-4a06-8a64-5fe678b607cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hybrid
• Version Model Number: HYB513
• Catalog Number: HYB513
• Company DUNS: 103307950
• Company Name: Innomed Technologies 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-200-9842
• Email: customerservice@innomedinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00833224000170 [Primary]
GS1	50833224000175 [Package]; Contains: 00833224000170; Package: [32 Units]; In Commercial Distribution
HIBCC	M694HYB5131 [Secondary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-15

On-Brand Devices [Hybrid]

• 50833224001196: Hybrid Frame System - LG
• 50833224001189: Hybrid Frame System - MD
• 50833224001172: Hybrid Frame System - SM
• 50833224001165: Hybrid Frame System - All Sizes Kit
• 50833224000236: Hybrid SLV Face Mask – All Sizes Kit
• 50833224000212: Hybrid Pillows - SM
• 50833224000205: Hybrid Pillows - MD
• 50833224000199: Hybrid Pillows - LG
• 50833224000182: Hybrid Cushion- SM
• 50833224000175: Hybrid Cushion- MD
• 50833224000168: Hybrid Cushion- LG
• 50833224000151: Hybrid Face Mask - All Sizes Kit