Prodigy Voice Blood Glucose Monitoring System 051900

GUDID 00384841519007

Prodigy Voice Blood Glucose Monitoring System (KIT)

PRODIGY DIABETES CARE, LLC

Manual blood lancing device, reusable
Primary Device ID00384841519007
NIH Device Record Key981d2a06-458f-4f78-b64b-9042087a9513
Commercial Distribution StatusIn Commercial Distribution
Brand NameProdigy Voice Blood Glucose Monitoring System
Version Model Number051900
Catalog Number051900
Company DUNS832875905
Company NamePRODIGY DIABETES CARE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.

Device Identifiers

Device Issuing AgencyDevice ID
GS100384840519008 [Primary]
GS100384840719507 [Primary]
GS100384841519007 [Direct Marking]
GS100384843519005 [Package]
Contains: 00384840519008
Package: Corrugated Carton [10 Units]
In Commercial Distribution
GS100384843719504 [Package]
Contains: 00384840719507
Package: Corrugated Carton [10 Units]
In Commercial Distribution

FDA Product Code

FMKLancet, Blood
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-22

Devices Manufactured by PRODIGY DIABETES CARE, LLC

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00384840517752 - PRODIGY Astro PRO Blood Glucose Monitoring System2020-09-30 PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients
00384841732000 - Prodigy No Coding Blood Glucose Test Strips2019-02-18 Prodigy No Coding Blood Glucose Test Strips (100 ct) with FREE AutoCode meter.
00384840810280 - Prodigy Twist Top Lancets2018-09-21 Prodigy Twist Top Lancets 28G (100 ct)
00384840823167 - Prodigy Pressure Activated Safety Lancets2018-09-21 Prodigy Pressure Activated Safety Lancets 26G (100 ct)
30384840823410 - Prodigy Pressure Activated Safety Lancets2018-09-21 Prodigy Pressure Activated Safety Lancets 21G (100 ct)
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