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

Basic Information

• Brand Name: Aero/Vent Plus, Aero/Vent Max, Aero/Vent Jr., Insta/Vent
• Primary DI: 00857863007369
• Version / Model: UV-204
• Company Name: Medi/Nuclear Corporation, Inc.
• Labeler DUNS: 079628327
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-09
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 2957a19b-e1d1-4f5a-aae6-24e337526951

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYT	System, Rebreathing, Radionuclide	Radiology	892.1390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40684	Teletherapy radionuclide system table, non-powered	A device that is a component of a teletherapy radionuclide system (commonly known as a cobalt therapy machine) and that is a non-electrical radiotherapy table specifically designed to position and support a patient during therapeutic radiation treatments administered using a radionuclide teletherapy system (e.g., a Cobalt-60 teletherapy system). It has a fixed position table top or mechanical table top positioning and/or table height controls, e.g., pneumatic controls, magnetic locks, cranks and lever mechanisms. It can be a stationary or mobile unit, or incorporated as an integral component of a radionuclide teletherapy system or gantry configuration.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857863007369	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K865107	000

Device Sizes

Type	Value	Unit	Text
Weight	110	Pound
Height	26	Inch
Depth	14	Inch
Width	19.5	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: store at room temperature