Nihon Kohden Life Scope G5 Bedside Monitoring System SB-950P

GUDID 04931921023624

Battery pack (for CU-151R, CU-152R)

NIHON KOHDEN CORPORATION

Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack
Primary Device ID04931921023624
NIH Device Record Key370f1f1d-5c90-45fe-b11a-81cd892a46b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNihon Kohden Life Scope G5 Bedside Monitoring System
Version Model NumberSB-950P
Catalog NumberSB-950P
Company DUNS690568050
Company NameNIHON KOHDEN 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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104931921023624 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-05
Device Publish Date2021-09-27

On-Brand Devices [Nihon Kohden Life Scope G5 Bedside Monitoring System]

04931921023624Battery pack (for CU-151R, CU-152R)
04931921002360Handle (for CU-151R, CU-152R)
04931921002179Software Kit (for CU-151R, CU-152R)
04931921002100Rear option board (for CU-151R, CU-152R)
04931921002094Recorder module (for CU-151R, CU-152R)
04931921002056Core Unit
04931921002018Core unit

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