Dispo-Med

Basic Information

• Brand Name: Dispo-Med
• Primary DI: 09555866300852
• Version / Model: DM-4601-14FTAST(U)
• Company Name: DISPO-MED (MALAYSIA) SDN. BHD.
• Labeler DUNS: 597426907
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-23
• Public Version: 1
• Public Version Date: 2022-05-31
• Public Version Status: New
• Public Device Record Key: 8ebb93d8-779c-4523-bc8d-01b605857238
• Distribution End Date: 2022-05-23

Device Description

Adult Nasal/Oral Dual CO2 Sampling Cannula w/O2 Delivery

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	868.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36306	Nasal oxygen cannula, carbon-dioxide-sampling	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09555866300852	GS1

Premarket Submissions

Submission Number	Supplement Number
K143127	000