FDA.reportPublic FDA data

SmartDose Evolution

Primary DI
00822383024875
Brand
SmartDose Evolution
Company
INOVO, INC.
Model
OM-975
Catalog number
OM-975
Device description
SmartDose Evolution Electronic Conserver
Published
2024-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
NFBConserver, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFBConserver, OxygenAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103392000CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVERInovo, Inc.2010-12-17NFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50822383024870PackageGS125In Commercial Distribution
00822383024875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5082238302487050822383024870
00822383024875008223830248758223830248750822383024875

GMDN Terms#

Term, Definition table
TermDefinition
Non-fixed medical gas cylinder regulatorA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height2.7Inch
Length6.2Inch
Width2.9Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
015954530
Device count
1
Serial number
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50822383024870SmartDose EvolutionOM-975OM-9752024-11-07
00814470020143EVOLUTION OM-900B2016-08-25
00814470020198EVOLUTION OM-904J2016-11-11
00814470020303EVOLUTION OM-903J2016-11-11
00814470020259OXYMIZERF-2242016-09-26
00814470020297BONSAI OM-810CE2021-09-20
00814470020235BONSAI OM-8102016-11-11
00814470020112OXYMIZERP-2242016-09-26
00814470020129OXYMIZERO-2242016-09-26
00822383018553EVOLUTION OM-9502023-05-25
00822383515557Evolution™OM-9242023-05-25
00822383504322DriveOM-8122023-10-16
00822383018522EVOLUTION OM-900CE2023-04-28
00822383018515DriveOM-900A2022-09-21
00814470020037BONSAI OM-8122016-06-28
00814470020044Evolution™OM-9002016-06-28
00814470020136EVOLUTION OM-9502016-08-25
00814470020150EVOLUTION OM-900A2016-08-25
00814470020204BONSAI OM-8242016-11-11
00814470020228EVOLUTION OM-900CE2016-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483599556AirLife™AIRLIFENFB2025-02-19
10889483605783AirLife™AIRLIFENFB2025-02-19
30889483599550AirLife™Sunmed Group Holdings, LLCNFB2025-02-19
30889483605787AirLife™Sunmed Group Holdings, LLCNFB2025-02-19
10889483605806AirLife™AIRLIFENFB2025-02-18
30889483605800AirLife™Sunmed Group Holdings, LLCNFB2025-02-18
00850027043746Precision MedicalPrecision Medical, Inc.NFB2024-12-12
50822383024870SmartDose EvolutionINOVO, INC.NFB2024-11-07
00850027997001DynarisIncoba LLCNFB2023-12-14
00822383504322DriveINOVO, INC.NFB2023-10-16
00822383018553EVOLUTION INOVO, INC.NFB2023-05-25
00822383515557Evolution™INOVO, INC.NFB2023-05-25
50822383018558EVOLUTION INOVO, INC.NFB2023-05-25
50822383515552Evolution™INOVO, INC.NFB2023-05-25
00822383018522EVOLUTION INOVO, INC.NFB2023-04-28
00822383018515DriveINOVO, INC.NFB2022-09-21
00814470020297BONSAI INOVO, INC.NFB2021-09-20
10080196193080MedlineMEDLINE INDUSTRIES, INC.NFB2021-03-31
10080196752287MedlineMEDLINE INDUSTRIES, INC.NFB2021-03-31
10190752115057Airlife™AIRLIFENFB2021-03-09
50190752115055Airlife™VYAIRE MEDICAL, INC.NFB2021-03-09
00855887006962Easy Pulse 5 Oxygen Conserving RegulatorPrecision Medical, Inc.NFB2021-03-05
00855887006627Easy Pulse 5 Oxygen Conserving RegulatorPrecision Medical, Inc.NFB2021-02-25
00854485007197ARES Nasal CannulaWatermark Medical, Inc.NFB2021-02-22
00822383274485driveDrive Devilbiss HealthcareNFB2020-07-01
00822383283814driveDrive Devilbiss HealthcareNFB2020-07-01
00822383284101driveDrive Devilbiss HealthcareNFB2020-07-01
00822383296401driveDrive Devilbiss HealthcareNFB2020-07-01
00885304002970DeVilbissDrive Devilbiss HealthcareNFB2020-04-03
00885304007197DeVilbissDrive Devilbiss HealthcareNFB2020-02-11