FDA UDI
In Commercial Distribution
🇺🇸 United States
IntelliVue Capnography Extension
DI: 00884838083578
·
Model: IntelliVue Capnography Extension
·
Philips Medizin Systeme Böblingen GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IntelliVue Capnography Extension
- Primary DI
- 00884838083578
- Version / Model
- IntelliVue Capnography Extension
- Catalog Number
- 867040
- 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
- 2019-04-11
- Public Version
- 4
- Public Version Date
- 2022-08-15
- Public Version Status
- Update
- Public Device Record Key
- 9166d2c7-2ae1-4581-8736-c247c94cd49b
Device Description
IntelliVue Capnography Extension works together with the IntelliVue Multi-Measurement Module (M3001A/AL), IntelliVue X2 Multi-Measurement Module (M3002A), IntelliVue MP2 Patient Monitor (M8102A), IntelliVue X3 (867030) and IntelliVue MX100 (867033). The base product provides CO2 waveform, inspired minimum (imCO2), endtidal CO2 (etCO2) and Airway Respiration Rate (awRR) of intubated and non-intubated adult, pediatric and neonatal patients varies care areas inside the hospital. Optional Right Heart Cardiac Output (C.O.), continuous C.O. PiCCO, dual Invasive Pressure and continuous Temperature measurement can be selected via B-options.
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
- No
- 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 |
|---|---|---|---|---|
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36553 | Patient monitoring system module, multifunction | A small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/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 | 00884838083578 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 57 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity