FDA.reportPublic FDA data

NA

Primary DI
00884838001404
Brand
NA
Company
Philips Medizin Systeme Böblingen GmbH
Model
989803103371
Catalog number
989803103371
Published
2016-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HFNTRANSDUCER, PRESSURE, INTRAUTERINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFNTransducer, Pressure, IntrauterineObstetrics/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
00884838001404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838001404008848380014048848380014040884838001404

GMDN Terms#

Term, Definition table
TermDefinition
Intrapartum pressure monitoring catheterA flexible tube with a pressure sensor, transducer, and/or thermistor located at its distal tip, used for intrapartum transcervical measurement of the intrauterine and amniotic pressures. It is attached at its proximal end via a signal cable to an external monitor that displays the pressure/temperature values, and is used to monitor the intensity, duration, and frequency of uterine contractions during labour. It may also be used for fluid infusion and sampling of amniotic fluid. It is typically made of plastic [e.g., polyethylene, polytetrafluoroethylene (PTFE) commonly known as Teflon, polyurethane] and/or silicone, and may include a catheter introducer/sheath. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
314101143
Device count
1
Lot or batch
true
Expiration date on label
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
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHHFN2021-03-08
B510FM30001ADVANCED FETAL MONITORADVANCED INSTRUMENTATIONS, INC.HFN2020-04-16
H671IUP4000INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP4500INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP5000INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP5500INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP6000INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP6500INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP7000INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP7500INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP4001INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP4501INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP5001INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP5501INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP6001INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP6501INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP7001INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
H671IUP7501INTRANUTAH MEDICAL PRODUCTS, INC.HFN2016-09-23
00814247020178Koala®CLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020154Koala®CLINICAL INNOVATIONS, LLCHFN2016-09-01
20814247020172Koala®CLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020192Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020208Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020215Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020222Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01
00814247020239Koala® CablesCLINICAL INNOVATIONS, LLCHFN2016-09-01