Aloha ALO100

GUDID 50833224000595

Aloha Nasal Pillows - All Sizes Kit

Innomed Technologies Inc

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 50833224000595
• NIH Device Record Key: eee1d0b2-6b8e-4ba9-be97-53628bf78abb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aloha
• Version Model Number: ALO100
• Catalog Number: ALO100
• 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: 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	00833224000590 [Primary]
GS1	50833224000595 [Package]; Contains: 00833224000590; Package: [30 Units]; In Commercial Distribution
HIBCC	M694ALO1001 [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 [Aloha]

• 00833224000729: Aloha Frame System - LG
• 00833224000712: Aloha Frame System - MD
• 00833224000705: Aloha Frame System - SM
• 00833224000620: Aloha Pillows - LG
• 50833224000618: Aloha Pillows - MD
• 50833224000601: Aloha Pillows - SM
• 50833224000595: Aloha Nasal Pillows - All Sizes Kit