Omron A.I.R..S. Nebulizer 9911

GUDID 00073796099114

Nebulizer

Omron Healthcare, Inc.

Nebulizing system delivery set, single-use

• Primary Device ID: 00073796099114
• NIH Device Record Key: a798a91a-2a95-4822-b9b6-0329c358a52a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron A.I.R..S. Nebulizer
• Version Model Number: 9911
• Catalog Number: 9911
• 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

Customer Support Contacts

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

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796099114 [Primary]
GS1	10073796099111 [Package]; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K870027

FDA Product Code

• CCQ: Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

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.

• 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.
• 10073796252554 - Silver Upper Arm Blood Pressure Monitor: 2024-05-23 Upper Arm Blood Pressure Monitor w/Bluetooth Connectivity, 30 Reading Memory, Easy Wrap ComFit Cuff
• 10073796271500 - 3 Series Upper Arm Blood Pressure Monitor: 2024-04-23 Automatic inflation upper arm blood pressure monitor with wide range cuff. (9-17 inch), Bluetooth connectivity, 14 memory storag
• 10073796272552 - Omron 5 Series Upper Arm Blood Pressure Monitor: 2024-04-23 Upper Arm Blood Pressure Monitor w/Bluetooth Connectivity, 30 Memory Storage, Extra Large Display, Irregular Heartbeat Detection
• 10073796423121 - Extra large D-ring Cuff for Telehealth Blood Pressure Monitor: 2022-08-09
• 10073796893108 - Blood Pressure Monitor: 2022-07-11 Telehealth Blood Pressure Monitor with extra large cuff compatibility.
• 00073796930004 - Blood Pressure Monitor: 2022-06-09 Telehealth Blood Pressure Monitor with range cup 9-17 inch.