nSpire Health

Basic Information

• Brand Name: nSpire Health
• Primary DI: 10852417003733
• Version / Model: KoKo Filter Kit
• Catalog Number: 851010
• Company Name: NSPIRE HEALTH, INC.
• Labeler DUNS: 184817096
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• 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: bd7fc640-b488-4e75-a0f1-2f37f6fc0bbb

Device Description

KoKo Standard Pulmonary Function Filter Kit, White with Cardboard Mouthpiece. 26.3mm ID x 30mm OD for use with MicroMedical, Vitalograph, Schiller, MultiSpiro/Creative Biomedics, MIR. Box of 100.

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
BYP	Mouthpiece, Breathing	Anesthesiology	868.5620	1
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	868.5260	2

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	10852417003733	GS1
Unit of Use	00852417003736	GS1