Drive

GUDID 50718122220392

Fire Truck Nebulizer w/ Disp NK

Drive Devilbiss Healthcare

Nebulizing system, non-heated

• Primary Device ID: 50718122220392
• NIH Device Record Key: 248e72f3-b956-4890-86e0-7bc353567d15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drive
• Version Model Number: MQ0911
• 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	00718122220397 [Primary]
GS1	50718122220392 [Package]; Contains: 00718122220397; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031413

FDA Product Code

• BTI: Compressor, air, portable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-28

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• 00822383984032: Spitfire 1320, 12AH, Red Shroud
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• 10822383982943: PumpOnly W/Connectors, BA9600 Series,1e
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• 00822383973425: Pressure PreventionGroup 1 Surfaces Product Description: 5 Zone Mattress with CPU cover-P/L 1501
• 00822383973258: Spitfire EX2, 4-Wheel 17" Seat, 21AH
• 00822383973241: Spitfire EX2, 4-Wheel 17" Seat, 12AH
• 00822383973234: Spitfire EX2, 3-Wheel 17" Seat, 21AH