cap-ONE

Basic Information

• Brand Name: cap-ONE
• Primary DI: 14931921902537
• Version / Model: YG-272T
• Company Name: NIHON KOHDEN CORPORATION
• Labeler DUNS: 690568050
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-02-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: e25e686e-2056-4dcd-9098-0ddfb2f6578d

Device Description

cap-ONE mask, adult

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
31339	Carbon dioxide monitor	A mains electricity (AC-powered) device intended to continuously measure the concentration of carbon dioxide (CO2) in a gas mixture through a particular method (e.g., electrochemical, infrared absorption, gas chromatographic, mass spectrometric) to determine a patient's ventilatory, circulatory, or metabolic status. It is typically used to measure end-tidal carbon dioxide (EtCO2) in expiratory gases during the administration of anaesthesia or during bedside monitoring. Commonly known as a capnograph or a capnometer, the sampling method can be "mainstream" and/or "sidestream".	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14931921902537	GS1
Unit of Use	04931921902530	GS1

Customer Contacts

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