Duns Number:314101143
Device Description: IntelliVue Cableless Respiration Pod, a battery-powered respiration device for frequent Ca IntelliVue Cableless Respiration Pod, a battery-powered respiration device for frequent Cableless Monitoring of patients. The IntelliVue CL Respiration Pod provides the respiration rate and optional the pulse rate via short range radio to the receiving system.
Catalog Number
865218
Brand Name
IntelliVue CL Respiration Pod
Version/Model Number
IntelliVue CL Respiration Pod
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
BZQ
Product Code Name
Monitor, breathing frequency
Public Device Record Key
78f88cce-8717-4d5e-825c-e4aa46b7fb85
Public Version Date
August 12, 2022
Public Version Number
6
DI Record Publish Date
December 28, 2016
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 |