Omron Mask and Mouthpiece Adapter U22-2

GUDID 00073796512224

Mask and Mouthpiece Adapter for Vibrating Mesh Nebulizer NE-U22V

Omron Healthcare, Inc.

Nebulizing system delivery set, single-use

• Primary Device ID: 00073796512224
• NIH Device Record Key: a2eba87b-9336-452f-9c55-187bcc27b2ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Mask and Mouthpiece Adapter
• Version Model Number: U22-2
• Catalog Number: U22-2
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com
• Phone: 1-800-634-4350
• Email: ohiquality@omron.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796222147 [Unit of Use]
GS1	00073796512224 [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.

• 10073796760066 - Upper Arm Blood Pressure Monitor: 2025-07-23 Omron Upper Arm Blood Pressure Monitor with Bluetooth smart connectivity. 100 memory storage for one user. One piece design.
• 10073796736535 - Blood Pressure Monitor: 2025-07-07 Upper Arm Blood Pressure Monitor with Possible AFib Detection Feature, 60 memory per user, 2 user total, Automatic Inflation, AC
• 10073796253605 - Gold Upper Arm Blood Pressure Monitor: 2025-02-03 Gold Upper Arm Blood Pressure Monitor with Wide-Range D-Ring Cuff, 80 memory readings with blue tooth connectivity, 2 user modes
• 00073796254650 - Platinum Upper Arm Blood Pressure Monitor: 2025-02-03 Platinum Upper Arm Blood Pressure Monitor with Wide-Range D-Ring Cuff, 100 memory readings with blue tooth connectivity, 2 user
• 00073796273606 - 7 Series Upper Arm Blood Pressure Monitor: 2025-01-08 7 Series Upper Arm Blood Pressure Monitor with Easy-Wrap ComFit Cuff, 60 memory readings, with blue tooth connectivity, 2 user m
• 00073796274658 - 10 Series Upper Arm Blood Pressure Monitor: 2025-01-08 10 Series Upper Arm Blood Pressure Monitor with Easy-Wrap ComFit Cuff, 100 memory readings, with blue tooth connectivity, 2 user
• 10073796250000 - Iron Upper Arm Blood Pressure Monitor: 2024-05-23 Upper Arm Blood pressure monitor, automatic inflation, wide range D-ring cuff 9"-17" inches.
• 10073796251502 - Bronze Upper Arm Blood Pressure Monitor: 2024-05-23 Upper Arm Blood Pressure Monitor Automatic Inflation with wide range cuff, and 14 memory readings.