FDA.reportPublic FDA data

Avalon Fetal & Maternal Patch

Primary DI
20884838059324
Brand
Avalon Fetal & Maternal Patch
Company
Philips Medical Systems Hsg
Model
Avalon CL Fetal & Maternal Patch
Catalog number
989803196341
Device description
Avalon CL Fetal & Maternal Patch to be used with Avalon CL Fetal & Maternal Pod 866488. Patch is Single Patient Use and consists of a cradle and 5 electrodes. 1 Box= 10 patches.
Published
2020-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
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
20884838059324PrimaryGS10
00884838059320Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088483805932420884838059324
00884838059320008848380593208848380593200884838059320

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 Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
790605856
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838048089Philips12-Lead Patient Cable (AAMI), Std Length9898031849312023-05-25
00884838048102Philips12-Lead Patient Cable (AAMI), Long9898031849512023-05-25
00884838012974NOUNPW CBL Complete Lead Set AAMI9898031516312016-12-06
00884838012981NOUNPW CBL Complete Lead Set IEC9898031516412016-12-06
00884838012998NOUNChest Lead Set, AAMI/IEC9898031516712016-12-06
00884838013001NOUNLong Chest Lead Set (Both AAMI and IEC)9898031516912016-11-11
00884838013025NOUNLimb Lead Set (Both AAMI and IEC)9898031517112016-11-03
00884838013032NOUNLong Limb Lead Set (Both AAMI and IEC)9898031517312017-06-07
00884838013049NOUNTC ADDITIONAL LEADS KIT: AAMI9898031517512017-05-11
00884838013056NOUNTC ADDITIONAL LEADS KIT: IEC9898031517612017-04-12
00884838014978NOUNLong Complete Lead Set AAMI9898031516512017-01-26
00884838014985NOUNPW CBL Long Complete Lead Set IEC9898031516612017-01-04
00884838014992NOUNTC ADDITIONAL LONG LEADS KIT: AAMI9898031517712017-11-08
00884838015005NOUNTC ADDITIONAL LONG LEADS KIT: IEC9898031517812017-04-28
00884838025479NOUNPW TC20 10-Lead Patient Cable IEC9898031758912016-10-06
00884838025486NOUNPW TC20 10-Lead Patient Cable AHA9898031759012016-11-23
00884838025493NOUNPW TC20 Long 10-Lead Patient Cable IEC9898031759112016-11-03
00884838025509NOUNPW TC20 Long 10-Lead Patient Cable AHA9898031759212016-10-06
00884838029118NOUN12L Leadset, Grabber, AAMI9898031801212016-12-19
00884838029125NOUN12L Leadset, Grabber, IEC9898031801312016-11-24

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
00884838068179Avalon CL Fetal & Maternal PodPhilips Medizin Systeme Böblingen GmbHHFM2020-05-22
00840682142571TOCO TRANSDUCERWIPRO GE HEALTHCARE PRIVATE LIMITEDHFM2018-11-01
00884838034235Avalon CL Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2016-10-19
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