Aspen ASP211

GUDID 00833224000774

Aspen Cushion - SM

Innomed Technologies Inc

CPAP/BPAP face mask, reusable

• Primary Device ID: 00833224000774
• NIH Device Record Key: 9588cad9-5500-43ec-bbf9-a2d39114f4f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspen
• Version Model Number: ASP211
• Catalog Number: ASP211
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00833224000774 [Primary]
GS1	50833224000779 [Package]; Package: [30 Units]; In Commercial Distribution
HIBCC	M694ASP2111 [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 [Aspen]

• 00833224000903: Aspen Full Face Mask - All Sizes Kit
• 00833224000798: Aspen Cushion - LG
• 00833224000781: Aspen Cushion - MD
• 00833224000774: Aspen Cushion - SM
• 00833224000767: Aspen Full Face Mask - LG
• 00833224000750: Aspen Full Face Mask - MD
• 00833224000743: Aspen Full Face Mask - SM