FDA UDI
In Commercial Distribution
🇺🇸 United States
Mainstream CO2 Sensor
DI: 00884838072145
·
Model: Mainstream Sensor
·
Philips Medizin Systeme Böblingen GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mainstream CO2 Sensor
- Primary DI
- 00884838072145
- Version / Model
- Mainstream Sensor
- Catalog Number
- 989803142651
- Company Name
- Philips Medizin Systeme Böblingen GmbH
- Labeler DUNS
- 314101143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-06
- Public Version
- 9
- Public Version Date
- 2023-05-05
- Public Version Status
- Update
- Public Device Record Key
- bf046093-7aed-4c9d-8d9f-2c9dc25c92f3
Device Description
Mainstream Sensor
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36552 | Patient monitoring system module, carbon dioxide | A small unit dedicated to the measurement of carbon dioxide (CO2) content of expired gas obtained through a sampling tube connected to a main respiratory channel (mainstream) or a side-channel (sidestream) of a breathing circuit. It is designed to operate as part of a patient monitoring system enhancing the function of this (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or in a connected module rack. The parent device operates as a mainframe computer displaying the CO2 parameter/information measured and provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838072145 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 57 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 159 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity