CMI Health
GUDID 00850000967007
CMI Health PC-900B Handheld Capnograph and Oximeter
CMI HEALTH INC.
Carbon dioxide monitor| Primary Device ID | 00850000967007 |
| NIH Device Record Key | 5a36680e-aec1-4962-a5ac-4287cf8926c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CMI Health |
| Version Model Number | PC-900B |
| 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 | |
| Phone | 888-985-1125 |
| info@cmihealth.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 120 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 120 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 120 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850000967007 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170820
FDA Product Code
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
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 | 2024-05-02 |
| Device Publish Date | 2024-04-24 |
On-Brand Devices [CMI Health]
| 00850000967007 | CMI Health PC-900B Handheld Capnograph and Oximeter |
| 00850000967052 | PC-66L Handheld Pulse Oximeter with Infant Foot Wrap Sensor |
| 00850000967038 | PC-66L Handheld Pulse Oximeter |
| 00850000967014 | PC-66L Pulse Oximeter with Adult Continuous Sensor |
Trademark Results [CMI Health]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CMI HEALTH 87795370 not registered Live/Pending |
CMI HEALTH INC 2018-02-13 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.