FDA.reportPublic FDA data

DISPO-MED

Primary DI
09555866300876
Brand
DISPO-MED
Company
DISPO-MED (MALAYSIA) SDN. BHD.
Model
DM-7100/CO-10FTST
Device description
The Gas Sampling lines are intended to interface with the patient via nasal canula, nares connector, or standard sampling port connectors to the expired gas monitor.
Published
2025-08-01
Public version status
New
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
K143127000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143127000CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only styleDispo-Med (Malaysia) Sdn Bhd2015-02-13CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09555866300876PackageGS125In Commercial Distribution
09555866301224PackageGS1100In Commercial Distribution
09555866301231PackageGS1800In Commercial Distribution
09555866300869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09555866300876095558663008769555866300876
09555866301224095558663012249555866301224
09555866301231095558663012319555866301231
09555866300869095558663008699555866300869

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
597426907
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
true
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
09555866301385DISPO-MEDDM-4601-AST(U)2026-04-02
09555866300869DISPO-MEDDM-7100/CO-10FTST2025-08-01
09555866300838Dispo-MedDM-7100/CO-3FTM2021-12-24
09555866301019Dispo-MedDM-7100-10FT2023-01-06
09555866300845Dispo-MedDM-4601-14FTALT(U)2022-05-23
09555866300852Dispo-MedDM-4601-14FTAST(U)2022-05-23
09555866300005Dispo-Med Nasal CO2 Sampling Cannula, Adult, MLL, Tube 7ftDM-4100-AM2016-11-04
09555866300012Dispo-Med Nasal CO2 Sampling Cannula, Adult, MLL, Tube 10ftDM-4100-10FTAM2016-11-04
09555866300029Dispo-Med Nasal CO2 Sampling Cannula, Paediatric, MLL, Tube 7ftDM-4100-PM2016-11-04
09555866300036Dispo-Med Nasal CO2 Sampling Cannula, Paediatric, MLL, Tube 10ftDM-4100-10FTPM2016-11-04
09555866300043Dispo-Med Nasal CO2 Sampling Cannula W/O2 Delivery, Adult, MLL, Tube 7ftDM-4000-AM2016-11-04
09555866300050Dispo-Med Nasal CO2 Sampling Cannula W/O2 Delivery, Adult, MLL, Tube 10ftDM-4000-10FTAM2016-11-04
09555866300067Dispo-Med Nasal CO2 Sampling Cannula W/O2 Delivery, Paediatric, MLL, Tube 7ftDM-4000-PM2016-11-04
09555866300074Dispo-Med Nasal/Oral Dual CO2 Sampling Cannula W/O2 Delivery,Adult,MLL,Tube 7ftDM-4601-AM2016-11-04
09555866300081Dispo-Med Nasal/Oral Dual CO2 Sampling Cannula W/O2 Delivery,Adult,MLL,Tube 10ftDM-4601-10FTAM2016-11-04
09555866300098Dispo-Med Nasal/Oral Dual CO2 Sampling Cannula W/O2 Delivery,Paed,MLL,Tube 7ftDM-4601-PM2016-11-04
09555866300104Dispo-Med Nasal/Oral Dual CO2 Sampling Cannula W/O2 Delivery,Paed,MLL,Tube 10ftDM-4601-10FTPM2016-11-04
09555866300111Dispo-Med Anaesthetic Gas Sampling Line, MLL, Tube 10FTDM-7100-10FTM2016-11-04
09555866300128Dispo-Med Airway adapterDM-7700-T2016-11-04
09555866300135Dispo-Med All purpose Sampling Line with T-Connector, MLL,Tube 7ftDM-7700-M2016-11-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884521858107NellcorCovidien LPCCK2026-05-29
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
10612479282190McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282213McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282237McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282251McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282275McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14