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Devices
Advance Microdraw Blood Glucose Monitoring System
Model / Serial
Part Number 411100, Lot Number: 09177A
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide: USA including states of CA, MI, MO, MS, NE, OH and TX.
Product Description
Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, Manufactured for ARKRAY USA, Inc., Minneapolis, MN 55439 USA. (Package Contents -Advance Micro-draw Blood Glucose Meter, 10 test Strips, Codeing chip and Control Solution (3mL), Lancing device, 10 Lancets, 3V Lithium Battery, Logbook, User Instruction Manual, Quick Reference Guide)
Manufacturer
ARKRAY USA INC.
1 Event
Recall of Advance Microdraw Blood Glucose Monitoring System
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Manufacturer
ARKRAY USA INC.
Manufacturer Address
ARKRAY USA INC., 5182 W 76th St, Minneapolis MN 55439-2900
Manufacturer Parent Company (2017)
Arkray Global Business Inc.
Source
USFDA
Language
English
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