nSpire Health

Basic Information

• Brand Name: nSpire Health
• Primary DI: 10852417003627
• Version / Model: KoKo Filter Kit
• Catalog Number: 810580
• Company Name: NSPIRE HEALTH, INC.
• Labeler DUNS: 184817096
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 70259289-6a20-4ab0-843a-e586325abe20

Device Description

KoKo Standard Blue Filter Kit with Nose Clip and Rubber Mouthpiece for use with KoKo Sx, KoKo Legend, KoKo Digidoser and KoKo Trek Spirometers. Box of 50.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	868.5260	2
BYP	Mouthpiece, Breathing	Anesthesiology	868.5620	1
BXJ	Clip, Nose	Anesthesiology	868.6225	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60506	Pulmonary function testing kit	A collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10852417003627	GS1
Unit of Use	00852417003620	GS1