Mesh Cap U100-4

GUDID 10073796011045

Mesh Cap for NE-U100 (MicroAir Vibrating Mesh Nebulizer)

Omron Healthcare, Inc.

Nebulizing system delivery set, single-use

• Primary Device ID: 10073796011045
• NIH Device Record Key: 6b3684d1-3898-4af8-b2b0-837fcca7c0b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mesh Cap
• Version Model Number: U100-4
• Catalog Number: U100-4
• Company DUNS: 054318779
• Company Name: Omron Healthcare, 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796011048 [Primary]
GS1	10073796011045 [Package]; Contains: 00073796011048; Package: Case [400 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-03
• Device Publish Date: 2018-10-31

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