FDA.reportPublic FDA data

Dispo-Med All purpose Sampling Line with T-Connector, MLL,Tube 7ft

Primary DI
09555866300135
Brand
Dispo-Med All purpose Sampling Line with T-Connector, MLL,Tube 7ft
Company
DISPO-MED (MALAYSIA) SDN. BHD.
Model
DM-7700-M
Published
2016-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
09555866300135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09555866300135095558663001359555866300135

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
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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
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

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