ARKRAY USA, INC.

ARKRAY USA, INC.

Address:Yousuien-nai,Kamigyo-ku Kyoto,JP

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Filters

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

Calculator/Data Processing Module, For Clinical Use (JQP) (3) Needle, hypodermic, single lumen (FMI) (2) Dispenser, Solid Medication (NXB) (2) AUTOMATED URINALYSIS SYSTEM (KQO) (2) DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) (JMT) (1) DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) (CDM) (1) DYE-INDICATOR, PH (URINARY, NON-QUANT.) (CEN) (1) INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) (JIR) (1) METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) (JIL) (1) NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) (JIN) (1) REFRACTOMETER FOR CLINICAL USE (JRE) (1) TEST, URINE LEUKOCYTE (LJX) (1) AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) (JJB) (1) BLOOD, OCCULT, COLORIMETRIC, IN URINE (JIO) (1) CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE (JQP) (1)

Premarket Exempt

No Yes

Clear

ARK Care® - 00015482000011 Catalog Number :

Device Description : ARK Care is a Diabetes Management System that is a solution for people with diab ARK Care is a Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.

Device Class : 1

Duns Number: 008171162

Premarket Exempt : No

Product Code : JQP

Prescription Use : No

Device Count : 1

ARK Care® Advance Diabetes Management System - 00015482000028 Catalog Number :

Device Description : ARK Care Advance is a Diabetes Management System that is a solution for people w ARK Care Advance is a Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.

Device Class : 1

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : No

Device Count : 1

ReliOn™ Life Patient Mobile Application - 00015482000035 Catalog Number :

Device Description : ReliOn Life is a patient mobile application of the ARK Care Advance Diabetes Man ReliOn Life is a patient mobile application of the ARK Care Advance Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.

Device Class : 1

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : No

Device Count : 1

ARK Care® VITA Patient Mobile Application - 00015482000042 Catalog Number :

Device Description : ARK Care VITA is a patient mobile application of the ARK Care Advance Diabetes M ARK Care VITA is a patient mobile application of the ARK Care Advance Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.

Device Class : 1

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : No

Device Count : 1

Assure® Slide Pill Swallowing Aid forte - 00015482100025 Catalog Number :

Device Description : Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a g Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100025 is used as the assigned UDI for the Class I device.)

Device Class : 1

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : NXB

Prescription Use : No

Device Count : 1

Assure® Slide Pill Swallowing Aid zero - 00015482100032 Catalog Number :

Device Description : Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a g Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100032 is used as the assigned UDI for the Class I device.)

Device Class : 1

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : NXB

Prescription Use : No

Device Count : 1

ASSURE® ID Insulin 1cc Safety Syringe - 00015482102913 Catalog Number :

Device Description : Sterile Safety Syringe

Device Class :

Duns Number: 008171162

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

ASSURE® ID Insulin 0.5cc Safety Syringe - 00015482102951 Catalog Number :

Device Description : Sterile Safety Syringe

Device Class :

Duns Number: 008171162

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

AUTION™ MAX AX-4022 Analyzer - 00015482129743 Catalog Number :

Device Description : Urine Analyzer utilize reflectance technology with with AUTION Strips reagent t Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity.

Device Class : 1

Duns Number: 008171162

Premarket Exempt : No

Product Code : JMT, JIN, JRE, JIR, JJB, JIO, KQO, CEN, CDM, JIL, LJX

Prescription Use : No

Device Count : 1

AUTION™ MAX AX-4030 Analyzer - 00015482145057 Catalog Number :

Device Description : Urine Analyzer utilize reflectance technology with with AUTION Strips reagent t Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity.

Device Class : 1

Duns Number: 008171162

Premarket Exempt : No

Product Code : KQO

Prescription Use : No

Device Count : 1

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