FDA.reportPublic FDA data

Resp-O2 Oxygen CO2 Sampling Line

Primary DI
00840117316065
Brand
Resp-O2 Oxygen CO2 Sampling Line
Company
DYNAREX CORPORATION
Model
33084
Device description
Resp-O2 Oxygen CO2 7' (2.1m) Sampling Line Male/Female Connector
Published
2021-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
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
00840117316065PackageGS125In Commercial Distribution
00840117316140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117316065008401173160658401173160650840117316065
00840117316140008401173161408401173161400840117316140

GMDN Terms#

Term, Definition table
TermDefinition
Capnography sampling adaptorA non-sterile device intended to enhance the capture of exhaled end-tidal carbon dioxide (EtCO2) for evaluation of a patient's ventilatory, circulatory, or metabolic status, typically during the administration of anaesthesia. It is an adhesive, dome-like adaptor with connecting ports designed to function as an interface between an in situ airway device (e.g., oropharyngeal airway, face mask, nasal oxygen cannula) and respiratory sampling tubing connected to a carbon dioxide monitor (capnograph). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117310346Resp-O2 Oxygen Cylinder Cart, Single366202026-10-28
00840117310353Resp-O2 Oxygen Cylinder Cart, Dual366212026-10-28
00840117310360Resp-O2 Oxygen Cylinder Holder, Wheelchair Mount366222026-10-28
00840117310278Resp-O2 Oxygen Cylinder Wrenches, Black366002026-10-26
00840117346222Resp-O2 M24 Oxygen E-Cylinder, With CGA 870 Post Valve, 4.55 L36390-PBULK2026-10-26
00840117322547Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363702026-10-23
00840117322554Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363712026-10-23
00840117322561Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363722026-10-23
00840117322578Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363732026-10-23
00840117322585Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363742026-10-23
00840117348684dmecare Solutions Folding Bedside Commode, With Collapsible Bucket10372C2026-10-23
00840117339057Durma+ Transparent Film Dressing, Frame Style, Sterile36472024-12-13
00840117339088Durma+ Transparent Film Dressing, Frame Style36482024-12-13
00616784319438Compress Bandages, Offset, Sterile31942021-06-21
00840117307360Child Face Masks2207-CHCR2021-06-21
00616784245119SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24512026-10-01
00616784245218SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24522026-10-01
00616784316925Cotton Balls, Large31692026-10-01
00616784317021Cotton Balls, Medium31702026-10-01
00616784671628SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrou67162026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860015046007XChangePneuma Therapeutics, Inc.CCK2026-10-16
10885403531521BD Alaris™ ETCO2 Module Model 8300CAREFUSION 303, INC.CCK2026-10-08
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyCCK2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyCCK2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyCCK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyCCK2026-10-04
10889483618264Air LifeAIRLIFECCK2026-08-26
10889483618271Air LifeAIRLIFECCK2026-08-26
10889483618288Air LifeAIRLIFECCK2026-08-26
10889483618295Air LifeAIRLIFECCK2026-08-26
10889483618301Air LifeAIRLIFECCK2026-08-26
10889483618318Air LifeAIRLIFECCK2026-08-26
00607411946684Salter LabsSALTER LABSCCK2026-08-03
00607411961342N/ASALTER LABSCCK2026-08-03
00607411947124N/ASALTER LABSCCK2026-07-28
00607411947131N/ASALTER LABSCCK2026-07-28
00607411947162N/ASALTER LABSCCK2026-07-28
04048675795124Sample Line 2,5mDrägerwerk AG & Co. KGaACCK2026-07-21
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