CMI Health
GUDID 00850000967007
CMI Health PC-900B Handheld Capnograph and Oximeter
CMI HEALTH INC.
Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor Carbon dioxide monitor 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 |
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 |
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