Somnics

GUDID 04719878320856

iBreath Breathing Training Kit

SOMNICS, INC.

Tongue/lip exerciser Tongue/lip exerciser Tongue/lip exerciser

• Primary Device ID: 04719878320856
• NIH Device Record Key: b2ea793c-d48f-4b38-b971-4a182d34d081
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Somnics
• Version Model Number: iBreath
• Company DUNS: 657169335
• Company Name: SOMNICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-833-766-6427
• Email: service.us@somnics.com
• Phone: 1-833-766-6427
• Email: service.us@somnics.com
• Phone: 1-833-766-6427
• Email: service.us@somnics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719878320856 [Primary]

FDA Product Code

• IOD: Components, Exercise

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-06
• Device Publish Date: 2022-11-28

On-Brand Devices [Somnics]

• 04719878320849: ZeeBud Plus Nasal Dilator (M1)
• 04719878320832: ZeeBud Nasal Dilator
• 04719878320856: iBreath Breathing Training Kit
• 04719878321044: ZEEPAP Nasal Dilator
• 04719878321082: ZeeBud Nasal Dilator (ZD1)