LiDCO Ltd Not a catalog item

GUDID 15060110522078

Smartcard, LiDCO LXi, 7 Days, Single Patient, Single

LIDCO LIMITED

Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor
Primary Device ID15060110522078
NIH Device Record Key59c65ceb-01b6-4615-902f-7ca68007d8aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameLiDCO Ltd
Version Model NumberLi10955
Catalog NumberNot a catalog item
Company DUNS345924427
Company NameLIDCO LIMITED
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com
Phone+4402077491500
Emailinfo@lidco.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060110522071 [Primary]
GS115060110522078 [Package]
Contains: 05060110522071
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXGCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2016-09-13

On-Brand Devices [LiDCO Ltd]

05060110522842CNAP Organiser Back Bracket, POC-125/127/W152
05060110522781* INACTIVE Software Upgrade, LiDCOunity v2.02 (b231)
05060110522620Software Upgrade, LiDCO LXI v2 for ICU Medical only (b1328)
05060110522613Software Upgrade, LiDCOrapid v2.06 (b1328)
05060110522606* INACTIVE Software Upgrade, LiDCOunity v1.01 (b1935)
05060110522590Desktop Stand, Height and Tilt Adjustable, POC-W152
05060110522583Desktop Stand, LiDCOunity v2 + CNAP, Demo Only
05060110522576Roll Stand Bracket Assembly, CNAP
05060110522569Bracket, POC-W152 + CNAP Demo Organiser, Aluminium
05060110522552Cable Assembly, USB ADC to GE 6/7000
05060110522545Cable Assembly, USB ADC to Fukuda Denshi DS8500
05060110522538Cable Assembly, USB ADC to Mindray T5 to T9
05060110522521Cable Assembly, USB ADC to Mindray iPM
05060110522514Cable Assembly, USB ADC to Mindray MPM
05060110522507Cable Assembly, USB, A-B, 0.9M
05060110522460User's Manual, LiDCOunity, LiDCOunity, V2, English
05060110522453User's Manual, LiDCOunity, LiDCOplus, V5.2, English
05060110522446User's Manual, LiDCOunity, LiDCOrapid, V3.2, English
05060110522378Licence, Software, LiDCOrapid (Rapid, BIS, Ext)
05060110522361Licence, Software, LiDCOunity (Rapid, Plus, Li, BIS, CNAP, Ext, Prod Sw)
05060110522354Licence, Software, LiDCOplus (Plus, Li, Ext)
05060110522347Licence, Software, LiDCOrapid, Li Calibration (Rapid, Li, CNAP, BIS, Ext)
05060110522330Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext)
05060110522309Cable Assembly, USB ADC to BNC
05060110522293Cable Assembly, USB ADC to Spacelabs
05060110522286Cable Assembly, USB ADC to Dräger
05060110522279Cable Assembly, USB ADC to Nihon Khoden 5-way ECG/BP OUT
05060110522262Cable Assembly, USB ADC to GE Marquette TRAM 451
05060110522255Cable Assembly, USB ADC to Datex S/5 with B-UPI4
05060110522248Cable Assembly, USB ADC to GE PDM Port
05060110522231Cable Assembly, USB ADC to Philips #C01 BP Module
05060110522224LiDCOunity Hemodynamic Assembly, Combined functionality, comprising of:
05060110522217LiDCOunity Hemodynamic Assembly, LiDCOplus functionality, comprising of:
05060110522200LiDCOunity Hemodynamic Assembly, LiDCOrapid functionality, comprising of:
05060110522194* INACTIVE Software Upgrade, LiDCO LXI v2 for ICU Medical only (b1326)
05060110522187* INACTIVE Software Upgrade, LiDCOrapid v2.06 (b1326)
05060110522156Software Upgrade, LiDCOunity v1.01 (b1935)
05060110522132Power Supply Unit, for LiDCOrapid Monitor (POC-125/-127/-W152)
05060110522125* INACTIVE Software Upgrade, LiDCOrapid v2.06 (b1324)
05060110522118BP Test Signal Generator, Handheld
15060110522078Smartcard, LiDCO LXi, 7 Days, Single Patient, Single
05060110522064LiDCO LXi Assembly, comprising of:
05060110522040LiDCO LXi Monitor
05060110522026LiDCOunity Hemodynamic Monitor, with Li-ion battery
05060110522002Smartcard, Demo, LiDCOunity, 60,000 Minutes
15060110521972Smartcard, LiDCOunity, CNAP, 7 Days, Single Patient, Single
05060110521968LiDCOrapid v2 Assembly with LiDCO CNAP Assembly, comprising:
05060110521937*INACTIVE Software Upgrade, LiDCOunity v1.01 (b1765)
05060110521890LiDCOunity Hemodynamic Assembly, Combined functionality, comprising of:
05060110521883LiDCOunity Hemodynamic Assembly, LiDCOplus functionality, comprising of:

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