Omron Mouthpiece for Vibrating Mesh Nebulizer U22-1

GUDID 00073796512217

Mouthpiece for Vibrating Mesh Nebulizer NE-U22V

Omron Healthcare, Inc.

Nebulizing system delivery set, single-use

• Primary Device ID: 00073796512217
• NIH Device Record Key: ed9524fa-dbc8-4572-a26e-15bbaec3f7b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Mouthpiece for Vibrating Mesh Nebulizer
• Version Model Number: U22-1
• Catalog Number: U22-1
• Company DUNS: 054318779
• Company Name: Omron Healthcare, Inc.
• Device Count: 12
• 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: 1-800-634-4350
• Email: ohiquality@omron.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796221140 [Unit of Use]
GS1	00073796512217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062263

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2017-05-17

Devices Manufactured by Omron Healthcare, Inc.

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• 00073796930004 - Blood Pressure Monitor: 2022-06-09 Telehealth Blood Pressure Monitor with range cup 9-17 inch.