Aero/Vent Plus, Aero/Vent Max, Aero/Vent Jr., Insta/Vent

GUDID 00857863007369

Universal Mobile Cabinet - Metal. (For Aero/Vent Plus, Aero/Vent Max, Aero/Vent Jr., and Insta/Vent Lead Shields Table Top). Powder coated steel almond color cabinet includes locking decay leaded area, storage area for supplies, swivel casters with front brakes and rubber bumpers on all corners. Oxygen tank holder is optional.

Medi/Nuclear Corporation, Inc.

Teletherapy radionuclide system table, non-powered

• Primary Device ID: 00857863007369
• NIH Device Record Key: 2957a19b-e1d1-4f5a-aae6-24e337526951
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aero/Vent Plus, Aero/Vent Max, Aero/Vent Jr., Insta/Vent
• Version Model Number: UV-204
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Width: 19.5 Inch
• Width: 19.5 Inch
• Width: 19.5 Inch
• Width: 19.5 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857863007369 [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.

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• 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
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• 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