Aura Medical

GUDID 00863943000120

Aura Medical

Ultrasonic nebulizing system

• Primary Device ID: 00863943000120
• NIH Device Record Key: d80ea55a-95d4-4531-ae36-22c7a9183c79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aura Medical
• Version Model Number: NB40
• Company DUNS: 052076745
• Company Name: Aura Medical
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	00863943000120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140211

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: 2020-02-24
• Device Publish Date: 2017-08-15

Devices Manufactured by Aura Medical

• 00085526400862 - Caring Mill by Aura Serene: 2024-11-22 Caring Mill by Aura Serene Menstrual Relief Tens Device
• 00863943000120 - Aura Medical: 2020-02-24
• 00863943000120 - Aura Medical: 2020-02-24