Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K143127
CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style · Dispo-Med (Malaysia) Sdn Bhd · decided 2015-02-13 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Dispo-Med CO2 Sampling Line,FLL | DM-7000-F | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300692 |
| Dispo-Med Single Port Emergency Nasal CO2 Cannula,Adult,MLL,Tube 7ft | DM-1000-AM | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300159 |
| CO2 Sampling Line for Microstream® (Oridion®) capnography | 93716000 | Intersurgical Incorporated | CCK | 00816472023726 |
| Dispo-Med Nasal CO2 Sampling Cannula,Paediatric,FLL, Tube 7ft | DM-4100-PF | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300241 |
| Curaplex | 301-4601-PST | TRI-ANIM HEALTH SERVICES, INC. | CCK | 00818834028219 |
| Dispo-Med Nasal CO2 Sampling Cannula,Adult,FLL, Tube 7ft | DM-4100-AF | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300234 |
| MedSource Sampling Cannula | MS-35400A14 | MEDSOURCE INTERNATIONAL LLC | CCK | 00840155413122 |
| Dispo-Med All purpose Sampling Line with T-Connector& Filter, MLL,Tube 10ft | DM-7700-10FTM(T) | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300753 |
| Dispo-Med Nasal CO2 Sampling Cannula W/O2 Delivery,Adult, MLL, Tube 7ft W/Filter | DM-4000-AST | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300470 |
| MedSource Sampling Cannula | MS-35400A10 | MEDSOURCE INTERNATIONAL LLC | CCK | 00840155413092 |
| Dispo-Med Nasal Dual CO2 Samp.Cannula W/O2 ,Adult,MLL,Tube 7ft W/Filter&Dryer | DM-4401-ALT | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300548 |
| ORI Airways | DM-7700-ST | Focal Point Logistics, LLC | CCK | 00860011532774 |
| Dispo-Med Single Port Emergency Nasal CO2 Cannula,Adult ,MLL,Tube 7ft W/Filter | DM-1000-AST | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300227 |
| Dispo-Med Nasal/Oral Dual CO2 Sampling Cannula W/O2 Delivery,Adult,FLL,Tube 7ft | DM-4601-AF | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300555 |
| Dispo-Med Anaesthetic Gas Sampling Line, FLL, Tube 7ft | DM-7100-F | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300739 |
| Dispo-Med Nasal/Oral CO2 Sampling Cannula,Adult ,MLL, Tube 7ft W/Filter | DM-2601-AST | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300333 |
| ORI Airways | DM-4000-10FTAM | Focal Point Logistics, LLC | CCK | 00860011532705 |
| Dispo-Med | DM-4000-AF(T) | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300777 |
| MEDLINE | HCS07GS | MEDLINE INDUSTRIES, INC. | CCK | 10197344162550 |
| Dispo-Med Single Port Emergency Nasal CO2 Cannula,Adult,FLL,Tube 7ft | DM-1000-AF | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300210 |
| ORI Airways | DM-7100/CO-8FTM | Focal Point Logistics, LLC | CCK | 00860011532767 |
| Dispo-Med Nasal CO2 Sampling Cannula,Adult ,MLL, Tube 7ft W/Filter & Dryer | DM-4100-ALT | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300272 |
| Dispo-Med Nasal CO2 Sampling Cannula,Paediatric ,MLL, Tube 7ft W/Filter& Dryer | DM-4100-PLT | DISPO-MED (MALAYSIA) SDN. BHD. | CCK | 09555866300289 |
| ORI Airways | DM-4000-10FTAF | Focal Point Logistics, LLC | CCK | 00860011532729 |
| Trinity Medical Devices | TOT804 | TRINITY MEDICAL DEVICES INC. | CCK | 00813880025908 |