VENTI-SCAN IV 177-075

GUDID 30718175005157

KIT, CONVENIENCE, VENTI-PAK FOR VENTI SCAN (ADAPTER KIT FOR VENTILATOR ASSISTED PATIENTS

BIODEX MEDICAL SYSTEMS, INC.

Radioaerosol administration set

• Primary Device ID: 30718175005157
• NIH Device Record Key: 50dbfc34-d7b9-4dee-bc9e-0638d07d9df7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTI-SCAN IV
• Version Model Number: 177-075
• Catalog Number: 177-075
• 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	00718175005156 [Primary]
GS1	10718175005153 [Package]; Contains: 00718175005156; Package: Box [5 Units]; In Commercial Distribution
GS1	20718175005150 [Package]; Contains: 00718175005156; Package: Box [10 Units]; In Commercial Distribution
GS1	30718175005157 [Package]; Contains: 00718175005156; Package: Box [15 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-12-13

On-Brand Devices [VENTI-SCAN IV]

• 30718175005157: KIT, CONVENIENCE, VENTI-PAK FOR VENTI SCAN (ADAPTER KIT FOR VENTILATOR ASSISTED PATIENTS
• 00718175087626: Venti-Scan IV, Includes shielded canister with IV pole mount