Omron Nebulizer Kit with Air Tube and Mouthpiece C900

GUDID 00073796390006

Nebulizer Kit with Air Tube and Mouthpiece

Omron Healthcare, Inc.

Nebulizing system delivery set, single-use

• Primary Device ID: 00073796390006
• NIH Device Record Key: 84f16fbf-af42-435d-a372-295639de463a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Nebulizer Kit with Air Tube and Mouthpiece
• Version Model Number: C900
• Catalog Number: C900
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796390006 [Primary]
GS1	10073796390003 [Package]; Package: Case [50 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-17

On-Brand Devices [Omron Nebulizer Kit with Air Tube and Mouthpiece]

• 00073796801458: Nebulizer Kit with Air Tube and Mouthpiece for NE-C801
• 00073796390006: Nebulizer Kit with Air Tube and Mouthpiece