Dispo-Med Duo-Flow O2+CO2 Sampling Cannula,Paedi,MLL,Tube 7ft W/Filter & Dryer

GUDID 09555866300449

DISPO-MED (MALAYSIA) SDN. BHD.

Nasal oxygen cannula, carbon-dioxide-sampling
Primary Device ID09555866300449
NIH Device Record Keyaef93ad7-232b-4851-b240-ae036540c877
Commercial Distribution StatusIn Commercial Distribution
Brand NameDispo-Med Duo-Flow O2+CO2 Sampling Cannula,Paedi,MLL,Tube 7ft W/Filter & Dryer
Version Model NumberDM-6500-PLT
Company DUNS597426907
Company NameDISPO-MED (MALAYSIA) SDN. BHD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109555866300449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-03-22
Device Publish Date2016-11-16

Devices Manufactured by DISPO-MED (MALAYSIA) SDN. BHD.

09555866300845 - Dispo-Med2022-05-31 Adult Nasal/Oral CO2 Sampling Cannula w/O Delivery
09555866300852 - Dispo-Med2022-05-31 Adult Nasal/Oral Dual CO2 Sampling Cannula w/O2 Delivery
09555866300005 - Dispo-Med Nasal CO2 Sampling Cannula, Adult, MLL, Tube 7ft2022-03-22
09555866300012 - Dispo-Med Nasal CO2 Sampling Cannula, Adult, MLL, Tube 10ft2022-03-22
09555866300029 - Dispo-Med Nasal CO2 Sampling Cannula, Paediatric, MLL, Tube 7ft2022-03-22
09555866300036 - Dispo-Med Nasal CO2 Sampling Cannula, Paediatric, MLL, Tube 10ft2022-03-22
09555866300043 - Dispo-Med Nasal CO2 Sampling Cannula W/O2 Delivery, Adult, MLL, Tube 7ft2022-03-22
09555866300050 - Dispo-Med Nasal CO2 Sampling Cannula W/O2 Delivery, Adult, MLL, Tube 10ft2022-03-22

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