DEVICE: Prodigy Voice Blood Glucose Monitoring System (00384840519008)

Device Identifier (DI) Information

Prodigy Voice Blood Glucose Monitoring System
051900
In Commercial Distribution
051900
PRODIGY DIABETES CARE, LLC
00384840519008
GS1

1
832875905 *Terms of Use
Prodigy Voice Blood Glucose Monitoring System (KIT)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
Yes
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Manual blood lancing device, reusable A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.
Glucose IVD, control A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.
Glucose IVD, kit, electrometry A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.
Home-use/point-of-care blood glucose monitoring system IVD A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
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FDA Product Code

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Product Code Product Code Name
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
FMI Needle, Hypodermic, Single Lumen
CGA Glucose Oxidase, Glucose
NBW System, Test, Blood Glucose, Over The Counter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

981d2a06-458f-4f78-b64b-9042087a9513
March 29, 2018
2
September 22, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00384843519005 10 00384840519008 In Commercial Distribution Corrugated Carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
Yes
00384841519007
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Production Identifier(s) in UDI

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Yes
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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