BP Pump 2M 2249049

GUDID 00850540007201

Non-Invasive Blood Pressure Simulator and Tester

FLUKE ELECTRONICS CORPORATION

Noninvasive blood pressure simulator
Primary Device ID00850540007201
NIH Device Record Key8cca9b00-7e33-4522-a96f-ddb67d1deade
Commercial Distribution StatusIn Commercial Distribution
Brand NameBP Pump 2M
Version Model NumberBPPUMP2M-US120V
Catalog Number2249049
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 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850540007201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

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

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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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