FDA.reportPublic FDA data

Mission Trinity B, Level 3

Primary DI
00811403014828
Brand
Mission Trinity B, Level 3
Company
Diamond Diagnostics Inc.
Model
DD-96003
Device description
For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter.
Published
2023-06-05
Public version status
New
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
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811403014828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811403014828008114030148288114030148280811403014828

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas analyte IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
947514303
Device count
1
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
07613336235546PreciControl HIV Gen IIRoche Diagnostics GmbHJJY2026-05-22
05391523442558 Multichem CSF Plus TECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442565 Multichem CSF Plus TECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442572Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442589Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442596Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442602Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442619Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442626Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
03701700819400ELITROL IVITALSCIENTIFICJJY2026-03-04
03701700819509ELITROL IIVITALSCIENTIFICJJY2026-03-04
07333066024035EliA IgM Calibrator WellPhadia ABJJY2026-01-29
05430003908518LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908525LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908532LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908549LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908556LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908563SEEKER®Lacar MDX TechnologiesJJY2026-01-15
05051700020602EXENT® Immunoglobulin Isotypes (GAM) Control PackTHE BINDING SITE GROUP LIMITEDJJY2025-11-27
07613336216965PreciControl Phospho-Tau (181P) PlasmaRoche Diagnostics GmbHJJY2025-11-18
00884883009301MAS Omni•IMMUNE Max, Level 1Microgenics CorporationJJY2025-08-12
00884883009318MAS Omni•IMMUNE Max, Level 2Microgenics CorporationJJY2025-08-12
00884883009325MAS Omni•IMMUNE Max, Level 3Microgenics CorporationJJY2025-08-12
00884883009332MAS Omni•IMMUNE Max, Sample PackMicrogenics CorporationJJY2025-08-12
00884883009349MAS Omni•IMMUNE PRO Max, Level 1Microgenics CorporationJJY2025-08-12
00884883009356MAS Omni•IMMUNE PRO Max, Level 2Microgenics CorporationJJY2025-08-12
00884883009363MAS Omni•IMMUNE PRO Max, Level 3Microgenics CorporationJJY2025-08-12
00884883009370MAS Omni•IMMUNE PRO Max, Sample PackMicrogenics CorporationJJY2025-08-12
04250317552747Dried Blood ControlChromsystems Instruments + Chemicals GmbHJJY2025-07-31
04250317552754Dried Blood ControlChromsystems Instruments + Chemicals GmbHJJY2025-07-31