SmartDose Evolution

Basic Information

• Brand Name: SmartDose Evolution
• Primary DI: 00822383024875
• Version / Model: OM-975
• Catalog Number: OM-975
• Company Name: INOVO, INC.
• Labeler DUNS: 015954530
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-07
• Public Version: 1
• Public Version Date: 2024-11-15
• Public Version Status: New
• Public Device Record Key: 52da6f99-676e-4192-aa8a-1a6c05fe6c32

Device Description

SmartDose Evolution Electronic Conserver

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
NFB	Conserver, Oxygen	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43438	Non-fixed medical 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 medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) cylinder to reduce high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). 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 it may have associated devices (e.g., a manometer, flowmeter) to display the available gas reserve of a gas cylinder, the working pressure and/or the flow rate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50822383024870	GS1	Master Carton	25	In Commercial Distribution
Primary	00822383024875	GS1

Premarket Submissions

Submission Number	Supplement Number
K103392	000

Device Sizes

Type	Value	Unit	Text
Length	6.2	Inch
Width	2.9	Inch
Height	2.7	Inch

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: – 93 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: – 93 Percent (%) Relative Humidity