DEVICE: Prodigy Control Solution Low (00384840533103)

Device Identifier (DI) Information

Prodigy Control Solution Low
053310
In Commercial Distribution
053310
PRODIGY DIABETES CARE, LLC
00384840533103
GS1

1
832875905 *Terms of Use
Prodigy Control Solution Low 4mL
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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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

[?]
Storage and Handling
Special Storage Condition, Specify: Store between 35.6°F to 86°F (2°C to 30°C). Do not freeze.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

38882a82-3d38-49e7-b01c-94ab6fc8f12a
March 29, 2018
2
September 22, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00384842533101 1000 00384840533103 In Commercial Distribution Corrugated Box
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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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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