SpiroFit

GUDID 00850000967649

Respiratory muscle training mask

Primary Device ID	00850000967649
NIH Device Record Key	e889aa57-01fc-4156-938c-f7f0fe222a24
Commercial Distribution Status	In Commercial Distribution
Brand Name	SpiroFit
Version Model Number	PF-T1
Company DUNS	079963616
Company Name	CMI HEALTH INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	00850000967649 [Primary]

ISD	Exerciser, Measuring

Steralize Prior To Use	false
Device Is Sterile	false

00850000967328 - SpiroLoop	2026-03-16 Portable PC-Based Pulmonary Function Test System
00850000967625 - SpiroLink 2 Pro	2026-03-16 SpiroLink 2 Pro Smart Handheld PFT
00850000967649 - SpiroFit	2026-03-16Respiratory Muscle Measuring Exerciser
00850000967649 - SpiroFit	2026-03-16 Respiratory Muscle Measuring Exerciser
00850000967014 - CMI Health	2025-05-01 PC-66L Pulse Oximeter with Adult Continuous Sensor
00850000967038 - CMI Health	2025-05-01 PC-66L Handheld Pulse Oximeter
00850000967052 - CMI Health	2025-05-01 PC-66L Handheld Pulse Oximeter with Infant Foot Wrap Sensor
00850000967304 - OxyKnight	2024-07-11 OxyKnight Fingertip Oximeter CF-100
00850000967403 - OxyKnight	2024-07-11 OxyKnight Fingertip Oximeter CF-100B

Mark Image Registration \| Serial	Company Trademark Application Date
SPIROFIT 85685919 4682419 Live/Registered	TV Free Media, LLC 2012-07-24