SpiroLoop
GUDID 00850000967328
Portable PC-Based Pulmonary Function Test System
CMI HEALTH INC.
Pulmonary function analysis system, adult| Primary Device ID | 00850000967328 |
| NIH Device Record Key | 97fb8075-ecd4-44ea-be4e-f192f4169501 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpiroLoop |
| Version Model Number | PF-A9 |
| Company DUNS | 079963616 |
| Company Name | CMI HEALTH INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
Customer Support Contacts
| Phone | 888-985-1125 |
| info@cmihealth.com | |
| Phone | 888-985-1125 |
| info@cmihealth.com | |
| Phone | 888-985-1125 |
| info@cmihealth.com | |
| Phone | 888-985-1125 |
| info@cmihealth.com | |
| Phone | 888-985-1125 |
| info@cmihealth.com | |
| Phone | 888-985-1125 |
| info@cmihealth.com | |
| Phone | 888-985-1125 |
| info@cmihealth.com | |
| Phone | 888-985-1125 |
| info@cmihealth.com | |
| Phone | 888-985-1125 |
| info@cmihealth.com | |
| Phone | 888-985-1125 |
| info@cmihealth.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 34 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 34 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 34 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 34 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 34 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 34 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 34 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 34 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 34 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 60 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 10 Degrees Celsius and 34 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850000967328 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231561
FDA Product Code
| BTY | Calculator, Predicted Values, Pulmonary Function |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-16 |
| Device Publish Date | 2026-03-06 |
Devices Manufactured by CMI HEALTH INC.
| 00850000967328 - SpiroLoop | 2026-03-16Portable PC-Based Pulmonary Function Test System |
| 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 | 2026-03-16 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 |
Trademark Results [SpiroLoop]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPIROLOOP 88692567 not registered Live/Pending |
CMI Health Inc. 2019-11-14 |
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