FDA.reportPublic FDA data

PHILIPS Cordless Ultrasound Transducer

Primary DI
00884838002685
Brand
PHILIPS Cordless Ultrasound Transducer
Company
Philips Medizin Systeme Böblingen GmbH
Model
862489
Catalog number
862489
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGMSYSTEM, MONITORING, PERINATAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023931000PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727APhilips Medical Systems, Inc.2003-02-24HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838002685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838002685008848380026858848380026850884838002685

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.

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
00884838120358Thermal Printer Kit, USBThermal Printer Kit, USB9898032050112026-06-04
00884838073715NMT cableIntelliVue NMT Patient Cable9898031745812017-03-21
00884838111462MR Patient Care Wireless ECG 3.0 Module (Networks 6-10)Wireless ECG 3.0 Module (Networks 6-10)9898031943412025-06-02
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
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
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
00884838119116Telemetry AccessoriesECG 6 lead Grabber, IEC, Tele9898031719612026-05-26
00884838119123Telemetry AccessoriesECG 6 lead Grabber, IEC + SpO2, Tele9898031719712026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.HGM2026-03-18
B153301010AirStrip ONE Client iOSAirstrip Technologies, Inc.HGM2026-03-18
B153301020AirStrip ONE Client AndroidAirstrip Technologies, Inc.HGM2026-03-18
05051968048233SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048240SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048257SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048264SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048271SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048288SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048295OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048301OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048318OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048325OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048332OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048349OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048356OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048363OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048370OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048387OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048394OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048400OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048417OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048424OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048431OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
06944413814714Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413819726Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413819733Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413807112Remote Event MarkerEdan Instruments, Inc.HGM2025-11-29
00860003483565PeriWatch SurveillancePERIGEN INC.HGM2025-11-24
00198953043271CareIntellect PerinatalGe Medical Systems Information Technologies, Inc.HGM2025-11-21