FDA.reportPublic FDA data

Avalon CL Toco+ MP Transducer

Primary DI
00884838034235
Brand
Avalon CL Toco+ MP Transducer
Company
Philips Medizin Systeme Böblingen GmbH
Model
Avalon Cableless Toco+ MP Transducer
Catalog number
866075
Device description
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.
Published
2016-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HFMMONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFMMonitor, Uterine Contraction, External (For Use In Clinic)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140535000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140535000PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50Philips Medizin Systeme Boblingen GmbH2014-11-25HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838034235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838034235008848380342358848380342350884838034235

GMDN Terms#

Term, Definition table
TermDefinition
Cardiotocography telemetric monitoring system transmitterA body-worn, battery-powered component of a cardiotocography telemetric monitoring system designed to continuously measure and wirelessly transmit foetal heart rate and uterine contraction signals to the system's receiver. The transmitter typically includes an antenna and attached sensors (e.g., lead wires and electrodes) that are connected to the patient.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure57 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
314101143
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838119192Telemetry AccessoriesTelemetry Adapter Masimo SpO2-only9898032023912026-05-28
00884838119208Telemetry AccessoriesECG 5L Grabber, AAMI, Masimo SpO2 , Tele9898032024112026-05-28
00884838119215Telemetry AccessoriesECG 5L Grabber, IEC, Masimo SpO2 , Tele9898032024212026-05-28
00884838119222Telemetry AccessoriesTelemetry Adapter 6-Lead + Masimo SpO29898032042912026-05-28
00884838094826Cardiac WorkstationCardiac Workstation 50008604392025-01-24
00884838094833Cardiac WorkstationCardiac Workstation 70008604412025-01-24
00884838132320Patient Information Center iXPatient Information Center iX 4.88663892026-07-13
00884838132337Care AssistCare Assist iOS 4.89898032215312026-07-13
00884838132344Care AssistCare Assist Android 4.89898032215412026-07-13
00884838119017Telemetry AccessoriesECG 3 lead Grabber, AAMI + SpO2, Tele9898031718112026-05-28
00884838119024Telemetry AccessoriesECG 5 lead Snaps, AAMI, Tele9898031718212026-05-28
00884838119031Telemetry AccessoriesECG 5 lead Grabber, AAMI, Tele9898031718312026-05-28
00884838119048Telemetry AccessoriesECG 5 lead Snaps, AAMI + SpO2, Tele9898031718412026-05-28
00884838119055Telemetry AccessoriesECG 5 lead Grabber, AAMI + SpO2, Tele9898031718512026-05-28
00884838119062Telemetry AccessoriesECG 6 lead Grabber, AAMI, Tele9898031718612026-05-28
00884838119185Telemetry AccessoriesTelemetry Adapter 5-Lead + Masimo SpO29898032023812026-05-28
00884838119079Telemetry AccessoriesECG 6 lead Grabber, AAMI + SpO2, Tele9898031718712026-05-26
00884838119086Telemetry AccessoriesECG 3 lead Grabber, IEC + SpO2, Tele9898031719112026-05-26
00884838119093Telemetry AccessoriesECG 5 lead Grabber, IEC, Tele9898031719312026-05-26
00884838119109Telemetry AccessoriesECG 5 lead Grabber, IEC + SpO2, Tele9898031719512026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
20884838059324Avalon Fetal & Maternal PatchPhilips Medical Systems HsgHFM2020-05-25
00884838068179Avalon CL Fetal & Maternal PodPhilips Medizin Systeme Böblingen GmbHHFM2020-05-22
00840682142571TOCO TRANSDUCERWIPRO GE HEALTHCARE PRIVATE LIMITEDHFM2018-11-01
00884838002715Avalon TOCO+ TransducerPhilips Medizin Systeme Böblingen GmbHHFM2016-10-03
00884838021471Avalon TOCO MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2016-10-03
M745FM10839AIVAMERICAN IV PRODUCTS, INC.HFM2016-09-02
M745FM10840AIVAMERICAN IV PRODUCTS, INC.HFM2016-09-02
M745FM10841AIVAMERICAN IV PRODUCTS, INC.HFM2016-09-02
00814247020284Koala Toco®CLINICAL INNOVATIONS, LLCHFM2016-09-01
20814247020288Koala Toco®CLINICAL INNOVATIONS, LLCHFM2016-09-01
B249VA000380FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA000381FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA001060FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA001061FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002020FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002030FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002190FEATHERLITE AQUAPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002191FEATHERLITE AQUAPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003100FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003101FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003110FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003111FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003120FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003121FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
00840682104111N/AWIPRO GE HEALTHCARE PRIVATE LIMITEDHFM2016-06-24