ICON 2

Basic Information

• Brand Name: ICON 2
• Primary DI: 00810051632446
• Version / Model: 1539117300
• Catalog Number: 1539117300-1
• Company Name: Control Devices, LLC
• Labeler DUNS: 119290896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-02
• Public Version: 1
• Public Version Date: 2025-06-10
• Public Version Status: New
• Public Device Record Key: ba9bf6e3-6edb-4573-af96-5152e0e10164

Device Description

Oxygen VIPR, CGA 540, DISS 1240, 0-25 L/min

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: 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
ECX	Cylinder, Compressed Gas, And Valve	Anesthesiology	868.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60970	Fixed medical gas cylinder regulator	A gas-regulating component of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) cylinder to reduce high, variable gas pressure to a lower, constant working pressure. It typically includes a cylinder shut-off switch (i.e., cylinder valve), regulator controls, manometer(s), a refill port, and a safety relief valve to avoid excessive pressure due to increased ambient temperatures. It is intended to be permanently fitted by a manufacturer to the stem of a valveless (i.e., open) empty medical gas cylinder prior to filling.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810051632446	GS1