Aerocare

GUDID 10822383561070

Aerocare, Pacifica Elite Neb

Drive Devilbiss Healthcare

Nebulizing system, non-heated

• Primary Device ID: 10822383561070
• NIH Device Record Key: fe4367c7-62de-4b6c-b281-f50fb2a3cda0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aerocare
• Version Model Number: 18071-Aerocare
• Company DUNS: 867673159
• Company Name: Drive Devilbiss Healthcare
• 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: 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	00822383561073 [Primary]
GS1	10822383561070 [Package]; Contains: 00822383561073; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003344

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: 2016-09-16

On-Brand Devices [Aerocare]

• 10822383561094: Aerocare, Penguin Compressor Neb
• 10822383561087: Aerocare, Penguin Compressor Neb
• 10822383561070: Aerocare, Pacifica Elite Neb
• 10822383295043: Aerocare, Sportneb