Duns Number:314101143
Device Description: The Avalon CL Fetal & Maternal Pod enables the Avalon wearable solution. It is used togeth The Avalon CL Fetal & Maternal Pod enables the Avalon wearable solution. It is used together with the Avalon CL Basestation 866074.
Catalog Number
866488
Brand Name
PHILIPS Avalon CL Fetal & Maternal Pod
Version/Model Number
Avalon CL Fetal & Maternal 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
HFM
Product Code Name
Monitor, uterine contraction, external (for use in clinic)
Public Device Record Key
7fbb5a25-9839-47f2-ac7d-1ed35a354583
Public Version Date
August 15, 2022
Public Version Number
4
DI Record Publish Date
May 22, 2020
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 |