Duns Number:314101143
Device Description: Avalon Cableless Toco+ MP Transducer for use with Avalon CL Basestation 866074. Toco Trans Avalon Cableless Toco+ MP Transducer for use with Avalon CL Basestation 866074. Toco Transducer with Avalon Smart Pulse measurement and connector for maternal ECG, fetal ECG or IUP measurement.
Catalog Number
866075
Brand Name
PHILIPS Avalon CL Toco+MP Transducer
Version/Model Number
Avalon Cableless Toco+ MP Transducer
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
ab313c63-54a9-4442-9402-86500b28f350
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 |