Amvex Vacuum Regulator

Basic Information

• Brand Name: Amvex Vacuum Regulator
• Primary DI: 00628101501358
• Version / Model: I2P
• Company Name: OHIO MEDICAL, LLC
• Labeler DUNS: 005192885
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-08-23
• Public Version Status: Update
• Public Device Record Key: 91d2dae9-282e-41b3-9101-610d6f82835f

Device Description

VR-I2 series, VacReg, Int 2Mode 300mmHg, Analog (kPa)

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
KDP	Regulator, Vacuum	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44809	Vacuum suction regulator/regulation set, general-purpose	A noninvasive device/collection of noninvasive devices designed to connect to the terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure during the evacuation of fluids, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). It allows continuous and/or intermittent suction at variable levels, incorporates a manometer and controls for monitoring/adjusting the level of suction, and may include collection containers, tubing or a stand/mount; it does not include patient contact devices (e.g., handpiece/tip, catheter).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628101501358	GS1

Customer Contacts

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