Duns Number:314101143
Device Description: IntelliVue Capnography Extension works together with the IntelliVue Multi-Measurement Modu 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.
Catalog Number
867040
Brand Name
IntelliVue Capnography Extension
Version/Model Number
IntelliVue Capnography Extension
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
9166d2c7-2ae1-4581-8736-c247c94cd49b
Public Version Date
August 15, 2022
Public Version Number
4
DI Record Publish Date
April 11, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 209 |