FDA.reportPublic FDA data

LiDCO Ltd

Primary DI
15060110521019
Brand
LiDCO Ltd
Company
LIDCO LIMITED
Model
Li10673
Catalog number
Not a catalog item
Device description
Smartcard, LiDCOrapid, 7 Days, Single Patient, Single
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXGCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXGComputer, Diagnostic, Pre-Programmed, Single-FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010049000PULSECO HEMODYNAMIC MONITOR CM71Lidco, Ltd.2001-06-14DXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060110521019PackageGS15In Commercial Distribution
05060110521012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506011052101915060110521019
05060110521012050601105210125060110521012

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4402077491500info@lidco.com

Regulatory Flags#

DUNS number
345924427
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060110520107LiDCO LtdCM 10 PASNot a catalog item2016-09-07
05060110520251LiDCO LtdCM 40Not a catalog item2016-09-07
05060110520329LiDCO LtdLi10949Not a catalog item2016-09-07
05060110521012LiDCO LtdLi10673Not a catalog item2016-09-13
05060110521418LiDCO LtdLi10744Not a catalog item2016-09-13
05060110521807LiDCO LtdCM 50-001-01Not a catalog item2016-09-13
05060110521975LiDCO LtdLi10886Not a catalog item2016-09-13
05060110522071LiDCO LtdLi10955Not a catalog item2016-09-13
05060110522422LiDCOLi11085Not a catalog item2018-03-27
05060110522910LiDCOLi11191Not a catalog item2018-05-23
05060110520275LiDCO LtdHM 71-02 PLUSHM 71-02 PLUS2016-09-07
05060110520282LiDCO LtdHM 81-01 ASSEMBLYHM 81-01 ASSEMBLY2016-09-07
05060110520299LiDCO LtdLi10545Li105452016-09-07
05060110520305LiDCO LtdCM 35-01CM 35-012016-09-07
05060110520312LiDCO LtdCM 35-02CM 35-022016-09-07
05060110520343LiDCO LtdLi10529Li105292016-09-07
05060110520534LiDCO LtdLi10554Li105542016-09-07
05060110520541LiDCO LtdLi10592Li105922016-09-07
05060110520558LiDCO LtdLi10593Li105932016-09-07
05060110520565LiDCO LtdLi10106Li101062016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850044487103Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487110Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487127Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00850044487134Retia MedicalRETIA MEDICAL, LLCDXG2026-04-16
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDXG2026-04-15
00198953049181NAGE Healthcare Finland OyDXG2026-01-05
00198953066560NAGE Healthcare Finland OyDXG2026-01-05
07290020154101BB-613W Wrist-MonitorBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
07290020154309BB-613 H@H kitBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDDXG2025-03-05
00843997001823LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997002882LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017428LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017435LiDCOMASIMO CORPORATIONDXG2024-07-26
00843997017190LiDCOMASIMO CORPORATIONDXG2024-07-26
09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2024-07-10
00850044487011Retia MedicalRETIA MEDICAL, LLCDXG2024-02-01
17290013030044StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
27290013030041StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
47290013030045StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
07290013030047StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
77290013030046StarlingCHEETAH MEDICAL (ISRAEL) LTDDXG2023-12-12
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDXG2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDXG2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDXG2023-04-19
00195278524089NAGE Healthcare Finland OyDXG2023-04-19
00850044487004Retia MedicalRETIA MEDICAL, LLCDXG2023-02-21
09120073932990CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXG2022-06-09
00840682146111CARESCAPE B650GE Healthcare Finland OyDXG2022-05-13