Ohio

Basic Information

• Brand Name: Ohio
• Primary DI: 00628101560386
• Version / Model: HS-12U2-DFDFC4M
• Catalog Number: HS-12U2-DFDFC4M
• Company Name: OHIO MEDICAL, LLC
• Labeler DUNS: 005192885
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-10
• Public Version: 1
• Public Version Date: 2022-04-18
• Public Version Status: New
• Public Device Record Key: 58350b3c-aedb-4016-9a5e-49b60c793069

Device Description

12' HOSE ASMBLY U N2O DF*DF CON 1/4" MRI

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: 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
BYX	TUBING, PRESSURE AND ACCESSORIES	Anesthesiology	868.5860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63209	General-gas low pressure tubing, reusable	A non-sterile length of flexible tube intended to conduct compressed medical gas typically from a cylinder to a respiratory medical device outside of a static clinical environment (e.g., emergency CPAP device); it is not dedicated for use with a specific gas. The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 15 bar), having been reduced by a regulator from a high pressure. The tubing is available in various lengths, including standard coil lengths; it is not colour-coded. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628101560386	GS1

Customer Contacts

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