Ohio

Basic Information

• Brand Name: Ohio
• Primary DI: 00628101612863
• Version / Model: V1
• Catalog Number: 6700-0270-700
• Company Name: OHIO MEDICAL, LLC
• Labeler DUNS: 005192885
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-29
• Public Version: 1
• Public Version Date: 2021-05-07
• Public Version Status: New
• Public Device Record Key: 3cfdfbcc-7d3b-4b4d-9731-382ba80d5ca8

Device Description

Venturi

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
63647	Pneumatic suction regulator/regulation set	A noninvasive device/collection of noninvasive devices designed to convert positive gas pressure from a compressed gas supply, into negative pressure (the Venturi principle) for the evacuation of fluids, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). The device is designed to be connected to the gas supply (e.g., air, oxygen cannister) to achieve controlled continuous and/or intermittent suction at variable levels. It includes a manometer, an activation knob, and may include collection containers or tubing; 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	00628101612863	GS1

Customer Contacts

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