FDA.reportPublic FDA data

E-Ca Cassette Carton

Primary DI
00894472000251
Brand
E-Ca Cassette Carton
Company
OPTI MEDICAL SYSTEMS, INC.
Model
1
Catalog number
BP7560
Device description
E-Ca Cassette
Published
2019-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K131126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131126000OPTI CCA-TS2Opti Medical Systems, Inc.2013-08-22CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894472000251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894472000251008944720002518944720002510894472000251

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry enzyme IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801458279
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894472000237B Cassette1BP75622019-08-07
00894472000244OPTI CCA E Cassette1BP75872019-08-07
00894472000268OPTI CCA E-Cl Cassette1BP75592019-09-03
00894472000275OPTI CCA E-Glu Cassette1BP75642019-09-03
00894472000107OPTI Check Control Tri Level1HC70082019-08-06
00894472000114OPTI Check Plus1HC70092019-08-06
00894472000152OPTI Analyzer CCA TS 1GD70132019-08-07
00894472000176Comfort Sampler, Basic Kit1BP06102019-08-07
00894472000183Comfort Sampler Bulk1BP06202019-08-07
00894472000077OPTI Accessory Kit1GD70452019-08-06
00894472000138Comfort Sampler1BP06002019-08-06
00894472000145OPTI CCA TS Accessory Kit1BP70352019-08-06

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