Aero/Vent Plus, Aero/Vent Max

GUDID 00857863007345

Aero/Vent Plus and Aero/Vent Max Portable Shield, Aluminum Case

Medi/Nuclear Corporation, Inc.

Radioaerosol administration set

• Primary Device ID: 00857863007345
• NIH Device Record Key: 1ff14d81-2418-4dd8-8579-54745e930b8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aero/Vent Plus, Aero/Vent Max
• Version Model Number: AV-501A
• Company DUNS: 079628327
• Company Name: Medi/Nuclear Corporation, 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: 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

Customer Support Contacts

• Phone: 800-321-5981
• Email: cs@medinuclear.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857863007345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K865107

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: 2017-06-09

Devices Manufactured by Medi/Nuclear Corporation, Inc.

• 00850022357817 - Xenon Master: 2024-09-18 Drierite, Indicating Blue/White Blend, Plastic Jar, 1 Lb. for Xenon Administration System
• 00850022357824 - Xenon Master: 2024-09-18 Drierite, Indicating Blue/White Blend, Plastic Jar, 4 Lb. for Xenon Administration System
• 00850022357831 - Xenon Master: 2024-09-18 Soda Lime, Plastic Container, 4 Lb for Xenon Administration System
• 00850022357848 - Xenon Master: 2024-09-18 Xenon Administration Set: 1 EA MN0309: Face Mask, Air-Cushioned, Adult Size 5, with Injection Port & Bacteria Filter, Flexible
• 00850022357855 - Xenon Master: 2024-09-18 Xenon Administration Set: 1 EA MN0312: Air Cushion Face Mask with Direct Dose Luer Lock, Ultra-Flex tubing (extends 6-24 inches
• 00850022357176 - N/A: 2024-09-11 Drierite, Plastic Container, 5 Lb for Xenon Administration System
• 00850022357152 - N/A: 2024-06-17 Soda Lime, Plastic Container, 1 Lb for Xenon Administration System
• 00850022357770 - Xenon Master Administration Set: 2023-12-15 Xenon Administration Set: Tube, Injection Port, HEPA Filter and Face Mask