FDA.reportPublic FDA data

Daily Rinse Kit

Primary DI
00811403015870
Brand
Daily Rinse Kit
Company
Diamond Diagnostics Inc.
Model
ME-2118D
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CEMElectrode, Ion Specific, Potassium
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
JFPElectrode, Ion Specific, Calcium
JGSElectrode, Ion Specific, Sodium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811403015870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811403015870008114030158708114030158700811403015870

GMDN Terms#

Term, Definition table
TermDefinition
Wash/cleaning solution IVD, automated/semi-automated systemA concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
947514303
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811403011469Glucose Electrode MembraneBK-670597D2023-06-12
00811403011667Glucose ReagentBK-472500D2023-06-12
00811403011636Glucose ElectrodeBK-469499D2023-06-10
00811403011131Glucose Reagent BK-443355D2023-06-05
00811403011605Albumin ReagentBK-467858D2023-06-10
00811403015504Maintenance KitHM-XEA328ASD2023-06-13
00811403015511O-Ring KitHM-XEA486ORD2023-06-13
00811403018901Vaccuum Pump Rebuild KitCO-67030079D2023-06-13
00811403019045Compressor Rebuild KitSX-28144879D2023-06-13
00811403019052Compressor Rebuild KitSX-44368656D2023-06-13
00811403010028SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+0-DD-SMARTLYTEPLUS2023-06-05
00811403013289Wash PackCD-473497D2023-06-13
00811403010158Photometer LampOY-MU8550D2023-06-13
00811403010240Reference SolutionIL-09756904D2023-06-13
00811403013074Pump Tubing KitCD-105673D2023-06-13
00811403013173C1/C2 Cleaning SolutionCD-473389D2023-06-13
00811403010387Wash PackCD-473497D2023-06-13
00811403013296pH ElectrodeCD-476267D2023-06-13
00811403013302Calcium ElectrodeCD-476268D2023-06-13
00811403013319Potassium ElectrodeCD-476270D2023-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740215712AlinityABBOTT LABORATORIESJGS2025-10-08
00380740215712AlinityABBOTT LABORATORIESCEM2025-10-08
00054749005673i-STAT G3+ CartridgeAbbott Point of Care Inc.CHL2023-12-18
10054749005502i-STATABBOTT POINT OF CARE INC.CHL2020-10-05
10054749005519i-STATABBOTT POINT OF CARE INC.JFP2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.JGS2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CEM2020-05-01
00380740156855ARCHITECTABBOTT LABORATORIESCEM2019-10-31
00380740156855ARCHITECTABBOTT LABORATORIESJGS2019-10-31
00380740163372ARCHITECTAbbott GmbHCEM2019-08-15
00380740163372ARCHITECTAbbott GmbHJGS2019-08-15
00380740121686AlinityAbbott GmbHJGS2018-05-30
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJGS2018-01-24
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYCEM2018-01-24
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYCEM2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYJGS2018-01-24
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 COMPANYCEM2018-01-24
08426950807599GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJGS2018-01-24
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 COMPANYCEM2018-01-24
08426950807605GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYJGS2018-01-24
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 COMPANYJGS2018-01-24
08426950807612GEM Premier 5000 PAK BG/ISE/COOX 75 TESTINSTRUMENTATION LABORATORY COMPANYCEM2018-01-24
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
08426950807629GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYJGS2018-01-24
08426950807629GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYCEM2018-01-24