KoKo

Basic Information

• Brand Name: KoKo
• Primary DI: 05065016557028
• Version / Model: Wright Haloscale Respirometer
• Catalog Number: 700-021
• Company Name: KOKO PFT LTD
• Labeler DUNS: 225828364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-01
• Public Version: 1
• Public Version Date: 2023-08-09
• Public Version Status: New
• Public Device Record Key: 96e90593-ebe6-494e-88f7-e05a615bf8c7

Device Description

Wright Haloscale Respirometer

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• 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
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	868.1850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61544	Monitoring spirometer, mechanical	A portable mechanical device designed to continuously measure tidal and/or minute volume of a spontaneously-breathing or mechanically-ventilated patient, for the evaluation of the patient’s ventilatory status during intensive care treatment, anaesthesia, and postoperative recovery; it may also be used to measure tidal/minute volume and respiration rate delivered to a patient via the expiratory ports of resuscitation devices to evaluate their performance. It consists of an airflow-driven turbine/dial which indicates the air volume passed.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05065016557028	GS1
Previous	00852417003279	GS1

Premarket Submissions

Submission Number	Supplement Number
K091853	000