Respironics

Basic Information

• Brand Name: Respironics
• Primary DI: 00884838040014
• Version / Model: 1103409
• Catalog Number: 1103409
• Company Name: Respironics Novametrix, LLC
• Labeler DUNS: 093608594
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-14
• Public Version: 4
• Public Version Date: 2023-10-17
• Public Version Status: Update
• Public Device Record Key: 7ff9b8b8-f7d4-48d9-901f-ce7b4533e088

Device Description

CapnoTrak CO2 Nasal Cannula

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
CAT	CANNULA, NASAL, OXYGEN	Anesthesiology	868.5340	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66399	Nasal carbon-dioxide-sampling cannula	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place, to allow sampling of exhaled gas for carbon dioxide (CO2) monitoring; it is not intended to supply oxygen or other medical gases to the patient. It may include attached gas sampling tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838040014	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius