PS320 2583030

GUDID 00850540007164

Fetal Simulator

FLUKE ELECTRONICS CORPORATION

Multi-parameter device tester
Primary Device ID00850540007164
NIH Device Record Key4ad56fee-41e5-408f-945f-f2e2068c5fb5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePS320
Version Model NumberPS320
Catalog Number2583030
Company DUNS002687614
Company NameFLUKE ELECTRONICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850540007164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-24

Devices Manufactured by FLUKE ELECTRONICS CORPORATION

00850540007218 - ESA 6142019-04-12 Electrical Safety Analyzer
00850540007065 - ProSim 82018-07-06 Vital Signs Patient Simulator
00850540007072 - ProSim 42018-07-06 Vital Signs Patient Simulator
00850540007089 - ProSim 22018-07-06 Vital Signs Patient Simulator
00850540007096 - ProSim 32018-07-06 Vital Signs Patient Simulator
00850540007102 - ProSim SPOT Light2018-07-06 SpO2 Pulse Oximeter Analyzer
00850540007119 - Impulse 6000D2018-07-06 Defibrillator Analyzer
00850540007133 - Impulse 40002018-07-06 Defibrillator/Pacer Analyzer

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