Duns Number:314101143
Device Description: Avalon CL Basestation. Basestation for Avalon cableless transducers with three slots for f Avalon CL Basestation. Basestation for Avalon cableless transducers with three slots for fetal transducers and one slot for maternal parameters or range extenstion module.
Catalog Number
866074
Brand Name
PHILIPS Avalon CL Base Station
Version/Model Number
Avalon CL Basestation
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
DRG
Product Code Name
TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
Public Device Record Key
94225874-c0e7-41ba-8c33-38eb57dae289
Public Version Date
August 15, 2022
Public Version Number
6
DI Record Publish Date
October 19, 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 |