Aerotech I Radioaerosol Administration System 177-124

GUDID 00718175001240

Aerotech I Radioaerosol Administration System

BIODEX MEDICAL SYSTEMS, INC.

Radioaerosol administration set

• Primary Device ID: 00718175001240
• NIH Device Record Key: dc9d8b5b-8213-444c-b6ed-1b0ecd2d24f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aerotech I Radioaerosol Administration System
• Version Model Number: 177-124
• Catalog Number: 177-124
• Company DUNS: 043833813
• Company Name: BIODEX MEDICAL SYSTEMS, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00718175001240 [Primary]
GS1	10718175001254 [Package]; Package: Box [5 Units]; In Commercial Distribution
GS1	20718175001268 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	30718175001272 [Package]; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800023

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: 2018-09-06
• Device Publish Date: 2017-12-18

On-Brand Devices [Aerotech I Radioaerosol Administration System ]

• 00718175003244: AeroTech I Convenience Kit with small particle delivery system
• 00718175001240: Aerotech I Radioaerosol Administration System
• 00718175087633: AeroTech I Shield