FDA.reportPublic FDA data

Resp-O2 EtCO2 7' (2.1 m) Sampling Line, With Filter, Male/Female Connector

Primary DI
00840117316164
Brand
Resp-O2 EtCO2 7' (2.1 m) Sampling Line, With Filter, Male/Female Connector
Company
Dynarex Corporation
Model
33086
Published
2021-04-22
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
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
00840117316089PackageGS125In Commercial Distribution
00840117316164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117316089008401173160898401173160890840117316089
00840117316164008401173161648401173161640840117316164

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.

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
true
Serial number
false
Manufacturing date on label
true
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
00840117311411Resp-O2 Nasal O2 Cannula Cushion Tip331542021-04-22
00840117311435Resp-O2 Nasal O2 Cannula Cushion Tip331552021-04-22
00840117311459Resp-O2 Nasal O2 Cannula Cushion Tip331562021-04-22
00840117311473Resp-O2 Nasal O2 High Flow Cannula331602021-04-22
00840117311718Resp-O2 Nasal Oxygen Cannula Deluxe Ear Foam Covers333002021-04-22
00840117316416Resp-O2 Nasal O2 Cannula Cushion Tip331702021-04-22
00840117316423Resp-O2 Nasal O2 Cannula Cushion Tip331712021-04-22
00840117316430Resp-O2 Nasal O2 Cannula Cushion Tip331722021-04-22
00840117316447Resp-O2 Nasal O2 Cannula Cushion Tip331732021-04-22
00840117316454Resp-O2 Nasal O2 Cannula Cushion Tip331742021-04-22
00840117316461Nasal O2 Cannula Cushion Tip331752021-04-22
00840117316478Resp-O2 Nasal O2 Cannula Cushion Tip331762021-04-22
00840117316577Resp-O2 EtCO2 Nasal Sampling Cannula331802021-04-22
00840117316584Resp-O2 EtCO2 Nasal Sampling Cannula331812021-04-22
00840117316591Resp-O2 EtCO2 Nasal Sampling Cannula331822021-04-22
00840117316607Resp-O2 EtCO2 Nasal Sampling Cannula331832021-04-22
00840117316614Resp-O2 EtCO2 Nasal Sampling Cannula331842021-04-22
00840117316621Resp-O2 EtCO2 Nasal Sampling Cannula331852021-04-22
00840117316638Resp-O2 EtCO2 Nasal Sampling Cannula331862021-04-22
00840117316645Resp-O2 EtCO2 Nasal Sampling Cannulas331872021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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