Venti-Scan 177-091

GUDID 00718175001912

Venti-Scan disposable, 12" tubing

BIODEX MEDICAL SYSTEMS, INC.

Radioaerosol administration set

• Primary Device ID: 00718175001912
• NIH Device Record Key: 82a7f48e-8a22-411d-bcd8-ec872f8649c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venti-Scan
• Version Model Number: 177-091
• Catalog Number: 177-091
• 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	00718175001912 [Primary]
GS1	10718175001926 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	20718175001930 [Package]; Package: Box [25 Units]; In Commercial Distribution
GS1	30718175001944 [Package]; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K871868

FDA Product Code

• IYT: System, Rebreathing, Radionuclide

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: 2016-11-02

On-Brand Devices [Venti-Scan]

• 00718175001929: Venti-Scan 24" Tubing
• 00718175001912: Venti-Scan disposable, 12" tubing