Utopia AV UTO251

GUDID 00833224000309

Utopia AV Full Face Mask - SM

Innomed Technologies Inc

CPAP/BPAP face mask, single-use

• Primary Device ID: 00833224000309
• NIH Device Record Key: 51d8c9c7-8b80-4b51-9846-f9a782556b7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Utopia AV
• Version Model Number: UTO251
• Catalog Number: UTO251
• Company DUNS: 103307950
• Company Name: Innomed Technologies Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: 800-200-9842
• Email: customerservice@innomedinc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00833224000309 [Primary]
GS1	50833224000304 [Package]; Package: [30 Units]; In Commercial Distribution
HIBCC	M694UTO2511 [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 [Utopia AV]

• 00833224001047: Utopia AV Full Face Mask - LG (with Black Headgear)
• 00833224001030: Utopia AV Full Face Mask - MD (with Black Headgear)
• 00833224001023: Utopia AV Full Face Mask - SM (with Black Headgear)
• 00833224000323: Utopia AV Full Face Mask - LG
• 00833224000316: Utopia AV Full Face Mask - MD
• 00833224000309: Utopia AV Full Face Mask - SM