OXYMIZER

Primary DI
10814470020126
Brand
OXYMIZER
Company
INOVO, INC.
Model
O-224
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
K830009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K830009000OXYMIZERChad Therapeutics, Inc.1983-04-02NFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814470020126PackageGS124In Commercial Distribution
00814470020129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081447002012610814470020126
00814470020129008144700201298144700201290814470020129

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen therapy conserving regulatorA device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cylinder, and is used to regulate the high pressure of the supply to a safe working pressure which is delivered to the patient requiring oxygen therapy and ensuring that the prescribed (set/dialed) dosage of O2 is maintained at an accurate level. It acts both as a pressure reduction device and an O2 saving device. Commonly known as an oxygen conserving regulator it may be designed to provide a bolus of O2 to the patient by metering the gas over the normal inspiration/expiration phases, thus conserving it.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015954530
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00822383024875SmartDose EvolutionOM-975OM-9752024-11-07
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

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
00822383024875SmartDose EvolutionINOVO, INC.NFB2024-11-07
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