FDA.reportPublic FDA data

Avalon CL Fetal & Maternal Pod

Primary DI
00884838068179
Brand
Avalon CL Fetal & Maternal Pod
Company
Philips Medizin Systeme Böblingen GmbH
Model
Avalon CL Fetal & Maternal Pod
Catalog number
866488
Device description
The Avalon CL Fetal & Maternal Pod enables the Avalon wearable solution. It is used together with the Avalon CL Basestation 866074.
Published
2020-05-22
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)
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838068179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838068179008848380681798848380681790884838068179

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
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00884838073715NMT cableIntelliVue NMT Patient Cable9898031745812017-03-21
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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

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