Insta/Vent

Basic Information

• Brand Name: Insta/Vent
• Primary DI: 00857863007383
• Version / Model: IV-603
• 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: fe67e772-d665-43d2-9e77-0e6b892865ea

Device Description

Insta/Vent Mobile Cabinet. (For Insta/Vent Lead Shield). Mobile Cabinet constructed of wood and almond color formica. Includes sliding shelf that locks lead shield in place and brings it close to a patient, decay leaded area, storage area for supplies, swivel casters with front brakes. Oxygen tank 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	00857863007383	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K960397	000

Device Sizes

Type	Value	Unit	Text
Weight	139	Pound
Height	39	Inch
Depth	15.25	Inch
Width	20.75	Inch

Storage Conditions

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