DISPO-MED

GUDID 09555866300876

The Gas Sampling lines are intended to interface with the patient via nasal canula, nares connector, or standard sampling port connectors to the expired gas monitor.

DISPO-MED (MALAYSIA) SDN. BHD.

Nasal oxygen cannula, carbon-dioxide-sampling

• Primary Device ID: 09555866300876
• NIH Device Record Key: 044615c8-5006-4e72-a38f-9e3361676d3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISPO-MED
• Version Model Number: DM-7100/CO-10FTST
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09555866300869 [Primary]
GS1	09555866300876 [Package]; Contains: 09555866300869; Package: [25 Units]; In Commercial Distribution
GS1	09555866301224 [Package]; Package: [100 Units]; In Commercial Distribution
GS1	09555866301231 [Package]; Contains: 09555866301224; Package: [800 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-11
• Device Publish Date: 2025-08-01

On-Brand Devices [DISPO-MED]

• 09555866300838: CO2 Gas Sampling Line, MLL, Tube 3ft
• 09555866300821: CO2 Gas Sampling Line, MLL, Filter, Tube 10ft
• 09555866300814: CO2 Sampling Line, MLL, Tube 10FT
• 09555866300777: Nasal CO2 Sampling Cannula w/O2 Delivery, Adult, FLL, w/Filter
• 09555866300760: Nasal/Oral Dual CO2 Sampling Cannula w/O2 Delivery, w/Filter Size Adult, FLL, Tube 7ft
• 09555866300852: Adult Nasal/Oral Dual CO2 Sampling Cannula w/O2 Delivery
• 09555866300845: Adult Nasal/Oral CO2 Sampling Cannula w/O Delivery
• 09555866300876: The Gas Sampling lines are intended to interface with the patient via nasal canula, nares connec