FDA.reportPublic FDA data

iCa++ Quick™ Sampler

Primary DI
00630414609515
Brand
iCa++ Quick™ Sampler
Company
Siemens Healthcare Diagnostics Inc.
Model
11537817
Catalog number
11537817
Device description
The iCa++ Quick™ Sampler is designed for in vitro diagnostic use with lithium heparin tubes, for the measurement of ionized Calcium(iCa++) on RAPIDPoint 500 systems and RAPIDLab 1260/1265 systems. This is suitable for professional use in a point-of-careor central laboratory environment.
Published
2020-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JFPELECTRODE, ION SPECIFIC, CALCIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFPElectrode, Ion Specific, CalciumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192240000RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc.2020-03-27CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414609515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414609515006304146095156304146095150630414609515

GMDN Terms#

Term, Definition table
TermDefinition
Blood gas/haemoximetry analyser IVD, point-of-careA mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811403010028SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics Inc.JFP2023-06-05
00811403015870Daily Rinse KitDiamond Diagnostics Inc.JFP2023-06-05
00811403019892SmartLyte Electrolyte AnalyzerDiamond Diagnostics Inc.JFP2023-06-05
00630414606095epoc NXS HostEpocal IncJFP2020-06-18
10054749005519i-STATABBOTT POINT OF CARE INC.JFP2020-05-01
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONJFP2018-12-05
00386100002398Daily Cleaning Solution Kit MEDICA CORPORATIONJFP2018-12-04
00386100002893Calcium Na/K/Ca/pH AnalyzerMEDICA CORPORATIONJFP2018-12-04
00386100003067Na/K/Ca/pH Solution Pack MEDICA CORPORATIONJFP2018-12-04
00386100003111Na/K/Ca/pH Solution PackMEDICA CORPORATIONJFP2018-12-04
00386100003296Daily Rinse/Cleaning Solution Kit MEDICA CORPORATIONJFP2018-12-04
00856522006118CC CartridgeLifehealthJFP2018-04-23
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807599GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807605GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807612GEM Premier 5000 PAK BG/ISE/COOX 75 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807629GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807636GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807643GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807674GEM Premier 5000 PAK BG/ISE/COOX 150 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807681GEM Premier 5000 PAK BG/ISE/COOX/TBILI 150 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807698GEM Premier 5000 PAK BG/ISE/GL/COOX 150 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807704GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 150 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807735GEM Premier 5000 PAK BG/ISE/COOX 300 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807742GEM Premier 5000 PAK BG/ISE/COOX/TBILI 300 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807759GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807766GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807797GEM Premier 5000 PAK BG/ISE/COOX 450 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807803GEM Premier 5000 PAK BG/ISE/COOX/TBILI 450 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24