| Primary Device ID | 00850000967625 |
| NIH Device Record Key | 19be9f7e-4f32-49eb-ad7c-aeb8bdfc3e38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpiroLink 2 Pro |
| Version Model Number | PF-A3P |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850000967625 [Primary] |
| BTY | Calculator, Predicted Values, Pulmonary Function |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-16 |
| Device Publish Date | 2026-03-06 |
| 00850000967328 - SpiroLoop | 2026-03-16 Portable PC-Based Pulmonary Function Test System |
| 00850000967625 - SpiroLink 2 Pro | 2026-03-16SpiroLink 2 Pro Smart Handheld PFT |
| 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 |