Avalon Fetal & Maternal Patch 989803196341

GUDID 20884838059324

Philips Medical Systems

Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Cardiotocography telemetric monitoring system transmitter Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor
Primary Device ID20884838059324
NIH Device Record Keyf21853bf-14bf-4e5c-9f8c-969cfc091307
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvalon Fetal & Maternal Patch
Version Model Number989803196341
Catalog Number989803196341
Company DUNS078628040
Company NamePhilips Medical Systems
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(999)999-9999
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Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838059320 [Unit of Use]
GS120884838059324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HFMMonitor, uterine contraction, external (for use in clinic)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-02
Device Publish Date2020-05-25

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