FDA.reportPublic FDA data

Resp-O2 EtCO2 Nasal Sampling Cannula

Primary DI
00840117319561
Brand
Resp-O2 EtCO2 Nasal Sampling Cannula
Company
Dynarex Corporation
Model
33196
Device description
7' (2.1 m) Tubing, Female Luer Connector, Adult, Universal O2 Tubing Connector
Published
2022-04-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143150000CO2 monitoring line with and without in-line filterBesmed Health Business Corp2015-02-05CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117319578PackageGS125In Commercial Distribution
00840117319561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117319578008401173195788401173195780840117319578
00840117319561008401173195618401173195610840117319561

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, carbon-dioxide-samplingA semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117305311Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000301042021-04-22
00840117305335Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301052021-04-22
00840117305359Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301062021-04-22
00840117305373Resp-O2 Hygroscopic Condenser Humidifier HMEF 600301072021-04-22
00840117305397Resp-O2 Heat Moisture Exchange (HMEF) 1500 + (HEPA) Filter301122021-04-22
00840117305410Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult302012021-04-22
00840117305434Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult, HCH, CO2 Port302032021-04-22
00840117305458Resp-O2 Heat Moisture Exchanger (HME) 1500, HCH, CO2 Port, Flex Tube302042021-04-22
00840117305472Resp-O2 Heat Moisture Exchanger (HME) 600, HCH, CO2 Port, Pediatric302052021-04-22
00840117305496Resp-O2 Pediatric/Neonatal Mini Tracheostomy (HME) 50302102021-04-22
00840117305557Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303022021-04-22
00840117305885Resp-O2 Heat Moisture Exchanger (HME) Tracheostomy with Side Oxygen Port303092021-04-22
00840117312340Resp-O2 Tracheostomy Drain Sponges, Non-woven,4"x4", 6-Ply350502022-05-02
00840117318090Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex Tube302022021-04-22
00840117318113Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy303032021-04-22
00840117318137Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy303052021-04-22
00840117305519Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303002022-05-10
00840117305533Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303012022-05-10
00840117313545Resp-O2 Disposable Suction Canisters, 800 cc, Float Valve Shutoff, Locking Lid322012022-04-28
00840117305274Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500301012021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675723677Vista 300 Sidestream CO2 ModuleShanghai Draeger Medical Instrument Co.,Ltd.CCK2026-07-13
00607411919190Salter Labs® Nasal CannulaSALTER LABSCCK2026-06-10
00607411919213Salter Labs® Nasal CannulaSALTER LABSCCK2026-06-10
00607411919206MedTronic ETCo2 CannulaSALTER LABSCCK2026-06-09
10884521858077NellcorCovidien LPCCK2026-05-29
10884521858084NellcorCovidien LPCCK2026-05-29
10884521858091NellcorCovidien LPCCK2026-05-29
10884521858107NellcorCovidien LPCCK2026-05-29
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
10612479282190McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14