WAL-MART STORES, INC.

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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

Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (3) SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (2) Tape And Bandage, Adhesive (KGX) (2) Blood Pressure Cuff (DXQ) (1) GLUCOSE OXIDASE, GLUCOSE (CGA) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1)

Premarket Exempt

No Yes

Clear

ReliOn BP300W Wrist Blood Pressure Monitor - 00605388577221 Catalog Number :

Device Class :

Duns Number: 051957769

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

ReliOn™ Confirm/Micro Control - 00605388710055 Catalog Number :

Device Description : ReliOn Confirm/Micro Control contains a known amount of glucose that reacts with ReliOn Confirm/Micro Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly. Compare the control solution test result with the range printed on the test strip bottle.

Device Class : 1

Duns Number: 051957769

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

ReliOn™ Premier Control Solution Level 1 - 00605388780058 Catalog Number :

Device Description : ReliOn Premier Control Solution Level 1 contains a known amount of glucose that ReliOn Premier Control Solution Level 1 contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 605388780058 is used as the assigned UDI for the Class I device.)

Device Class : 1

Duns Number: 051957769

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

ReliOn™ Premier Control Solution Level 2 - 00605388780065 Catalog Number :

Device Description : ReliOn Premier Control Solution Level 2 contains a known amount of glucose that ReliOn Premier Control Solution Level 2 contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 605388780065 is used as the assigned UDI for the Class I device.)

Device Class : 1

Duns Number: 051957769

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

ReliOn® Confirm Pink Blood Glucose Monitoring System - 00605388860156 Catalog Number :

Device Description : Portable Blood Glucose Meter

Device Class : 2

Duns Number: 051957769

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ReliOn® Confirm Blue Blood Glucose Monitoring System - 00605388860163 Catalog Number :

Device Description : Portable Blood Glucose Meter

Device Class : 2

Duns Number: 051957769

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

ReliOn® Confirm/micro Blood Glucose Test Strips - 00605388860170 Catalog Number :

Device Description : Blood Glucose Test Strips

Device Class :

Duns Number: 051957769

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 20

RELION - 00605388878113 Catalog Number : 004017283

Device Description : Self Taking Blood Pressure Kit

Device Class :

Duns Number: 051957769

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

Equate - 00681131006712 Catalog Number :

Device Description : Flexible Fabric Bandages,Antibacterial, assorted sizes, 5/8 IN x 2-1/4 IN (15 mm Flexible Fabric Bandages,Antibacterial, assorted sizes, 5/8 IN x 2-1/4 IN (15 mm x 57 mm), 3/4 IN x 3 IN (19 mm x 76 mm), 1 INx 3 IN (25 mm x 76 mm)

Device Class :

Duns Number: 051957769

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 100

Equate - 00681131006729 Catalog Number :

Device Description : Flexible Fabric Bandages,Antibacterial, all one size, 2 IN x 4 IN (50 mm x 101 mm)

Device Class :

Duns Number: 051957769

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 10

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