Dynaris

Primary DI
00850027997001
Brand
Dynaris
Company
Incoba LLC
Model
902001
Published
2023-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NFBConserver, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFBConserver, OxygenAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200401000ApogeeIncoba Ltd D/B/A Dynaris2020-11-14NFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850027997001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850027997001008500279970018500279970010850027997001

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
930622050
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30889483599550AirLife™Sunmed Group Holdings, LLCNFB2025-02-19
30889483605787AirLife™Sunmed Group Holdings, LLCNFB2025-02-19
30889483605800AirLife™Sunmed Group Holdings, LLCNFB2025-02-18
00850027043746Precision MedicalPrecision Medical, Inc.NFB2024-12-12
50822383024870SmartDose EvolutionINOVO, INC.NFB2024-11-07
00822383504322BONSAI INOVO, INC.NFB2023-10-16
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
50190752115055Airlife™VYAIRE MEDICAL, INC.NFB2021-03-09
00855887006962Precision MedicalPrecision Medical, Inc.NFB2021-03-05
00855887006627Precision MedicalPrecision 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
00885304002963DeVilbissDrive Devilbiss HealthcareNFB2020-02-07
50190752115024AirLife™VYAIRE MEDICAL, INC.NFB2020-01-15
50190752115031AirLife™VYAIRE MEDICAL, INC.NFB2020-01-15
50190752115048AirLife™VYAIRE MEDICAL, INC.NFB2020-01-15
50190752115062AirLife™VYAIRE MEDICAL, INC.NFB2020-01-15
50190752115079AirLife™VYAIRE MEDICAL, INC.NFB2020-01-15
50190752115093AirLife™VYAIRE MEDICAL, INC.NFB2020-01-15