Dispo-Med Nasal CO2 Sampling Cannula W/O2 Delivery,Paed,MLL, Tube 7ft W/Filter

GUDID 09555866300487

DISPO-MED (MALAYSIA) SDN. BHD.

Nasal oxygen cannula, carbon-dioxide-sampling

• Primary Device ID: 09555866300487
• NIH Device Record Key: 696f3ea9-af60-4fec-8b9d-cdc5f6070cf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dispo-Med Nasal CO2 Sampling Cannula W/O2 Delivery,Paed,MLL, Tube 7ft W/Filter
• Version Model Number: DM-4000-PST
• Company DUNS: 597426907
• Company Name: DISPO-MED (MALAYSIA) SDN. BHD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09555866300487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143127

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-03-22
• Device Publish Date: 2016-11-16

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

• 09555866300845 - Dispo-Med: 2022-05-31 Adult Nasal/Oral CO2 Sampling Cannula w/O Delivery
• 09555866300852 - Dispo-Med: 2022-05-31 Adult Nasal/Oral Dual CO2 Sampling Cannula w/O2 Delivery
• 09555866300005 - Dispo-Med Nasal CO2 Sampling Cannula, Adult, MLL, Tube 7ft: 2022-03-22
• 09555866300012 - Dispo-Med Nasal CO2 Sampling Cannula, Adult, MLL, Tube 10ft: 2022-03-22
• 09555866300029 - Dispo-Med Nasal CO2 Sampling Cannula, Paediatric, MLL, Tube 7ft: 2022-03-22
• 09555866300036 - Dispo-Med Nasal CO2 Sampling Cannula, Paediatric, MLL, Tube 10ft: 2022-03-22
• 09555866300043 - Dispo-Med Nasal CO2 Sampling Cannula W/O2 Delivery, Adult, MLL, Tube 7ft: 2022-03-22
• 09555866300050 - Dispo-Med Nasal CO2 Sampling Cannula W/O2 Delivery, Adult, MLL, Tube 10ft: 2022-03-22