Sylent NE SYL271

GUDID 50833224000564

Sylent 2 NE Nasal Mask - SM

Innomed Technologies Inc

CPAP/BPAP nasal mask, single-use

• Primary Device ID: 50833224000564
• NIH Device Record Key: 0620fcf9-bb3b-4137-8912-943827e58499
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sylent NE
• Version Model Number: SYL271
• Catalog Number: SYL271
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00833224000569 [Primary]
GS1	50833224000564 [Package]; Contains: 00833224000569; Package: [30 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-15

On-Brand Devices [Sylent NE]

• 50833224000571: Sylent 2 NE Nasal Mask - MD
• 50833224000564: Sylent 2 NE Nasal Mask - SM