FDA.reportPublic FDA data

NICaS

Primary DI
07290015331005
Brand
NICaS
Company
NEW N.I. MEDICAL (2011) LTD
Model
CS
Device description
Bioimpedance Cardiac Analyzing Measuring System
Published
2023-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DSBPlethysmograph, Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080941000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080941000BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEMN.I. Medical, Ltd.2009-06-18DSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015331005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015331005072900153310057290015331005

GMDN Terms#

Term, Definition table
TermDefinition
Impedance cardiographA device that records the variations in thoracic electrical impedance caused by the activity of the heart muscle, usually detected at the body surface. A current is passed through the body and the product of this current and the body impedance is the electrical potential difference between two sensing electrodes. The graphic representation of the variation of the impedance with time is recorded in a diagram (impedance cardiogram). It is used to study the action of the heart muscle, for diagnosis of specific cardiac abnormalities, and to reveal trends or changes in heart function, especially cardiac output. Some types may include additional measurements (e.g., pulse oximetry, blood pressure).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600279405
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260451441180Osypka MedicalOsypka Medical GmbHDSB2026-04-24
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00690103219531Acumen IQ PlusEdwards Lifesciences LLCDSB2025-09-10
00690103219609VitaWaveEdwards Lifesciences LLCDSB2025-09-10
B719G73C0Valhalla Scientific, IncValhalla ScientificDSB2025-07-28
00690103219616ForeSight IQEdwards Lifesciences LLCDSB2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCDSB2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCDSB2025-07-11
00690103217957HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCDSB2025-03-13
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.DSB2025-03-13
00860006382315SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DSB2025-03-13
00860006382322SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DSB2025-03-13
00860006382339SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DSB2025-03-13
00860006382346SENSINEL™ CPM ALIGNMENT TOOLAnalog Devices, Inc.DSB2025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.DSB2025-03-13
00690103218879HemoSphere VitaEdwards Lifesciences LLCDSB2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCDSB2024-08-28
B719G62J0Valhalla Scientific, IncValhalla ScientificDSB2024-06-17
B719G63C0Valhalla Scientific, IncValhalla ScientificDSB2024-04-12
B719BE3B0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G61S0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G62Q0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G62S0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719G63S0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
B719HT3C0Valhalla Scientific, IncValhalla ScientificDSB2024-03-15
37630039301980IV PoleBracco Injeneering SADSB2024-03-01
37630039301997Floor StandBracco Injeneering SADSB2024-03-01