Microstream
GUDID 10884521844704
Microstream CO2 NanoPod
Covidien LP
Carbon dioxide monitor| Primary Device ID | 10884521844704 |
| NIH Device Record Key | ad229ec0-a106-4e10-a0be-0c55b1e42273 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Microstream |
| Version Model Number | PMC40M-SF-NK |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 11 KiloPascal and 108 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521844704 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213911
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 | 2024-09-16 |
| Device Publish Date | 2024-09-08 |
On-Brand Devices [Microstream]
| 10884521551992 | FILTERLINE H SET ADULT/PEDIATRIC 1 UN |
| 10884521551985 | FILTERLINE SET ADULT/PEDIATRIC 1 UN |
| 30884521551903 | ORIDION: SMART CAPNOLINE PLUS O2 ADULT/INT 1 UN |
| 10884521591721 | SMART CAPNOLINE PLUS O2 LONG A/INT ORI 1 UNIT |
| 20884521520797 | AC ADAP PKG USA |
| 20884521554068 | Microstream XXXX |
| 10884521799615 | CARESCAPE CO2-Microstream Parameter;For use with GE Patient Monitors |
| 10884521590809 | RS08674 |
| 10884521815353 | Medtronic Microstream (TM) CO2 NanoPod, Philips |
| 10884521815346 | Medtronic Microstream (TM) CO2 NanoPod |
| 10884521844704 | Microstream CO2 NanoPod |
Trademark Results [Microstream]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MICROSTREAM 97852335 not registered Live/Pending |
Tech 387 LLC 2023-03-22 |
 MICROSTREAM 88437409 not registered Live/Pending |
Tally USA, LLC 2019-05-20 |
 MICROSTREAM 77079033 3415213 Live/Registered |
Streamlight, Inc. 2007-01-09 |
 MICROSTREAM 76132568 2687148 Live/Registered |
NORTH AMERICAN FILTER CORPORATION 2000-09-22 |
 MICROSTREAM 75801317 2383103 Live/Registered |
ORIDION MEDICAL 1987 LTD. 1999-09-16 |
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