Omron Air Filters for NE-C30 C30FL

GUDID 00073796330620

Air Filters for NE-C30 Nebulizer

Omron Healthcare, Inc.

Non-respiratory device ambient air filter

• Primary Device ID: 00073796330620
• NIH Device Record Key: dcbaa83f-2ee3-4aab-bdc2-1215afea331e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Air Filters for NE-C30
• Version Model Number: C30FL
• Catalog Number: C30FL
• Company DUNS: 054318779
• Company Name: Omron Healthcare, Inc.
• Device Count: 5
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796306205 [Unit of Use]
GS1	00073796330620 [Primary]
GS1	10073796330627 [Package]; Package: Inner Carton [50 Units]; In Commercial Distribution
GS1	20073796330624 [Package]; Contains: 10073796330627; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060811

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: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2017-05-17

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