FDA.reportPublic FDA data

DISPO-MED

Primary DI
09555866301385
Brand
DISPO-MED
Company
DISPO-MED (MALAYSIA) SDN. BHD.
Model
DM-4601-AST(U)
Device description
Nasal Cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases.
Published
2026-04-02
Public version status
New
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
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
09555866302115PackageGS125In Commercial Distribution
09555866301385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09555866302115095558663021159555866302115
09555866301385095558663013859555866301385

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.

Regulatory Flags#

DUNS number
597426907
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09555866300869DISPO-MEDDM-7100/CO-10FTST2025-08-01
09555866300876DISPO-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10612479282299McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282312McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10197344162550MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-10-17
10197344162567MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-10-17
09555866300869DISPO-MEDDISPO-MED (MALAYSIA) SDN. BHD.CCK2025-08-01
10884389815311MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-25
10884389815069MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-24
10197344111107MEDLINEMEDLINE INDUSTRIES, INC.CCK2024-09-09
10841522126413TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCCK2024-07-16
10843997017685NomolineMASIMO CORPORATIONCCK2024-03-19
10620974003684Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2024-01-26
10620974003097Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003103Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003127Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003134Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003158Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003165Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003172Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003189Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003202Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003219Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003226Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003608Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003615Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003622Oxy2ProSouthmedic IncorporatedCCK2023-12-01