CLEWICU

Primary DI
07290018852002
Brand
CLEWICU
Company
CLEW MEDICAL LTD
Model
4.8
Published
2024-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNLMedium-Term Adjunctive Predictive Cardiovascular IndicatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200717000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200717000CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical , Ltd.2021-01-09QNL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018852002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018852002072900188520027290018852002

GMDN Terms#

Term, Definition table
TermDefinition
Clinical management support softwareAn application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Also known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600148544
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690103219616ForeSight IQEdwards Lifesciences LLCQNL2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCQNL2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCQNL2025-07-11
00690103217957HemoSphere AltaEdwards Lifesciences LLCQNL2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCQNL2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCQNL2025-03-13
03770025266015SignalHFImplicity Inc.QNL2024-04-16
B823AHIV200AHI SystemFifth Eye, Inc.QNL2022-02-12