2 Cyl. Portable Loaner

Basic Information

• Brand Name: 2 Cyl. Portable Loaner
• Primary DI: 00813830023046
• Version / Model: 42000-LOANER
• Catalog Number: 42000-LOANER
• Company Name: ACCUTRON, INC.
• Labeler DUNS: 088302096
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-28
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b3547e07-ff4b-4b73-af14-d8dab94f2c4c

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: Yes
• 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
BXH	Gauge, Gas Pressure, Cylinder/Pipeline	Anesthesiology	868.2610	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41756	Gas cylinder holder	A device designed to hold and secure a single medical gas cylinder of compressed medical gas which is to be used in medical treatment/therapy. The usual gases are, [e.g., oxygen (O2), air, or nitrous oxide (N2O)]. It is used to secure the cylinder both during transport and typically whilst the gas is being used. The device is typically constructed of metal and may be mounted to a medical device service rail system, a bed under transport, or other medical devices requiring medical gas to be present. It is configured to meet the size of the cylinder, typically those of small dimensions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813830023046	GS1