Zzoma

GUDID 00863826000315

The Zzoma Positional Device is an FDA-cleared positional medical device for the treatment of mild to moderate positional Obstructive Sleep Apnea (OSA).

2Z Medical

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• Primary Device ID: 00863826000315
• NIH Device Record Key: 4d3454d1-dca1-4183-b9da-76776edf2e0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zzoma
• Version Model Number: 001
• Company DUNS: 829477228
• Company Name: 2Z Medical
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877 799 9662
• Email: info@2zmedical.com
• Phone: 877 799 9662
• Email: info@2zmedical.com
• Phone: 877 799 9662
• Email: info@2zmedical.com
• Phone: 877 799 9662
• Email: info@2zmedical.com
• Phone: 877 799 9662
• Email: info@2zmedical.com
• Phone: 877 799 9662
• Email: info@2zmedical.com
• Phone: 877 799 9662
• Email: info@2zmedical.com
• Phone: 877 799 9662
• Email: info@2zmedical.com
• Phone: 877 799 9662
• Email: info@2zmedical.com
• Phone: 877 799 9662
• Email: info@2zmedical.com
• Phone: 877 799 9662
• Email: info@2zmedical.com
• Phone: 877 799 9662
• Email: info@2zmedical.com
• Phone: 877 799 9662
• Email: info@2zmedical.com
• Phone: 877 799 9662
• Email: info@2zmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863826000315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100160

FDA Product Code

• MYB: Pillow,Cervical(For Mild Sleep Apnea)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-11