FDA.reportPublic FDA data

LiDCO Ltd

Primary DI
05060110521586
Brand
LiDCO Ltd
Company
LIDCO LIMITED
Model
Li10800
Catalog number
Li10800
Device description
Li10800 BISx Assembly
Published
2017-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWQFull-montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122247000LIDCORAPID V2 MONITORLidco, Ltd.2013-03-20DXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060110521586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060110521586050601105215865060110521586

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
Serial number
true

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

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