MERCEDES MEDICAL, LLC

Address:12210 Rangeland Parkway,Lakewood Ranch,FL,34211,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Thin Layer Chromatography, Morphine (DNK) (8) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (8) Enzyme Immunoassay, Amphetamine (DKZ) (7) Enzyme Immunoassay, Cannabinoids (LDJ) (7) Thin Layer Chromatography, Methamphetamine (DJC) (7) Enzyme Immunoassay, Benzodiazepine (JXM) (6) Enzyme Immunoassay, Opiates (DJG) (5) Enzyme Immunoassay, Phencyclidine (LCM) (5) Enzyme Immunoassay, Methadone (DJR) (4) Enzyme Immunoassay, Barbiturate (DIS) (4) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (2) Tubes, Vials, Systems, Serum Separators, Blood Collection (JKA) (2)

Premarket Exempt

Clear

Vacuflow™ - 00850011007006 Catalog Number : MED 5021

Device Description : Butterfly, Vacuflow non-safety, w/adapter 21G 12" tubing 50/bx

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : JKA

Prescription Use : No

Device Count : 1

BluRapids™ - 00850011007013 Catalog Number : TNR MM5CMET

Device Description : BluRapids CLIA Waived Drug Cup; 5-Panel AMP/COC/MET/OPI/THC

Device Class : 2

Duns Number: 834472680

Premarket Exempt : No

Product Code : LDJ, DNK, DJC, DIO, DKZ

Prescription Use : No

Device Count : 1

BluRapids™ - 00850011007020 Catalog Number : TNR MM5CPCP

Device Description : BlueRapids CLIA Waived Drug Cup; 5-Panal AMP/COC/PCP/OPI2000/THC

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : LDJ, DNK, LCM, DIO, DKZ

Prescription Use : No

Device Count : 1

BluRapids™ - 00850011007037 Catalog Number : TNR CDOA261

Device Description : BlueRapids CLIA Waived Drug Cup; 6 Panel AMP/BZO/COC/MET/OPI2000/THC

Device Class : 2

Duns Number: 834472680

Premarket Exempt : No

Product Code : LDJ, DNK, DJC, DIO, JXM, DKZ

Prescription Use : No

Device Count : 1

BluRapids™ - 00850011007044 Catalog Number : TNR CDOA262

Device Description : BluRapids CLIA Waived Drug Cup; 6 Panel with Adulterants BZO/COC/MET/OPI/OXY/THC

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : LDJ, DJG, DNK, DJC, DIO, JXM

Prescription Use : No

Device Count : 1

Vacuflow™ - 00850011007051 Catalog Number : MED 5023

Device Description : Butterfly, Vacuflow non-safety, w/adapter 23G 12" tubing 50/bx

Device Class : 2

Duns Number: 834472680

Premarket Exempt : No

Product Code : JKA

Prescription Use : No

Device Count : 1

BluRapids™ - 00850011007068 Catalog Number : TNR CDOA6125

Device Description : BluRapids CLIA Waived Drug Cup; 12 panel AMP/ BAR/BUP/BZO/COC/MDMA/MET/MTD/OPI-3 BluRapids CLIA Waived Drug Cup; 12 panel AMP/ BAR/BUP/BZO/COC/MDMA/MET/MTD/OPI-300/OXY/ PCP/THC

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : LDJ, LCM, DNK, DJR, DJC, DIO, JXM, DJG, DIS, DKZ

Prescription Use : No

Device Count : 1

BluRapids™ - 00850011007075 Catalog Number : TNR CDOA5125A3

Device Description : BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BUP/BZO/COC/MTD/MDMA/MET/OPI200 BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BUP/BZO/COC/MTD/MDMA/MET/OPI2000/OXY/PCP/THC ; Adulterants: +pH, OX,SG

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : LDJ, LCM, DNK, DJC, DJR, DIO, JXM, DJG, DIS, DKZ

Prescription Use : No

Device Count : 1

BluRapids™ - 00850011007082 Catalog Number : TNR CDOA7125

Device Description : BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BZO/COC/MET/MDMA/OPI-300/MTD/OX BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/THC

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : LDJ, LFG, LCM, DJG, DJR, DNK, DJC, DIO, JXM, DIS, DKZ

Prescription Use : No

Device Count : 1

BluRapids™ - 00850011007099 Catalog Number : TNR MMC12MOP

Device Description : BluRapids CLIA Waived Drug Cup; 12 Panel BluRapids AMP/BAR/BUP/BZO/COC/MET/MDMA/ BluRapids CLIA Waived Drug Cup; 12 Panel BluRapids AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA

Device Class :

Duns Number: 834472680

Premarket Exempt : No

Product Code : LFG, LCM, DJR, DNK, DJC, DIO, JXM, DJG, DIS, DKZ

Prescription Use : No

Device Count : 1

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