BVI Medical

Basic Information

• Brand Name: BVI Medical
• Primary DI: 00819601025745
• Version / Model: ISPAN
• Catalog Number: SMPQBVI180@1S
• Company Name: Airgas Therapeutics, LLC
• Labeler DUNS: 118537769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-06
• Public Version: 1
• Public Version Date: 2025-06-16
• Public Version Status: New
• Public Device Record Key: b1a454eb-028c-4c67-971a-64ca61011305

Device Description

ISPAN Single Stage Regulator; CGA 180; For BVI

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	868.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48035	Intraocular gas cylinder regulator	A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a gas cylinder used to deliver intraocular gas [i.e., sulfur hexafluoride (SF6) or perfluoropropane (C3F8) used as a tamponade for retinal surgery] to lower high, variable gas pressure to a lower, constant working pressure. It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures and usually a manometer or manometers to display the available gas reserve of a gas cylinder and the working pressure.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819601025745	GS1

Customer Contacts

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