Aero/Vent Plus

GUDID 00857863007222

Aero/Vent Plus w/HEPA Filter & Mask

Medi/Nuclear Corporation, Inc.

Radioaerosol administration set

• Primary Device ID: 00857863007222
• NIH Device Record Key: 819af803-7fae-4381-8206-903928906d2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aero/Vent Plus
• Version Model Number: AV-400+M
• 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: true
• 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: true
• 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	00857863007055 [Primary]
GS1	00857863007222 [Package]; Contains: 00857863007055; Package: Carton [24 Units]; In Commercial Distribution

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

On-Brand Devices [Aero/Vent Plus]

• 00857863007994: Filter, HEPA, Disposable
• 00857863007918: Lead Adapter Replacement, Powder coated lead adapter with 7 ft. oxygen tube with secure fit conn
• 00857863007680: Elbow, 22mm OD x 22mm ID
• 00857863007673: Nose Clip, Disposable with Foam Nose Pads
• 00857863007550: Face Mask, Air-Cushioned, Adult Size 5, 22mm ID w/Adapter
• 00857863007543: Face Mask, Air-Cushioned, Adult Size 5, 22mm ID
• 00857863007239: Aero/Vent Plus Radioaerosol Unit w/HEPA Filter and Safety Shield Mouthpiece, and bacteria filter
• 00857863007246: Aero/Vent Plus Ventilator Kit w/HEPA Filter, For ventilator dependent patients
• 00857863007222: Aero/Vent Plus w/HEPA Filter & Mask
• 00857863007215: Aero/Vent Plus Radioaerosol Unit w/HEPA Filter