DEVICE: TRUENESS (00021292015107)

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Device Record History
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Device Identifier (DI) Information
TRUENESS
TRUENESS Control Solution
In Commercial Distribution

TRIVIDIA HEALTH, INC.
00021292015107
GS1

1
151810868 *Terms of Use
TRUENESS Control Solution Level 2
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
41819 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.
Active false
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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
Yes CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between 34 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: DO NOT FREEZE
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
9e4e293b-a72f-45af-b483-07f3c12efb42
April 11, 2024
1
April 03, 2024
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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
00021292015077 1 00021292015107 In Commercial Distribution Box
10021292015074 400 00021292015077 In Commercial Distribution Case
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Secondary DI

[?]
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

[?]
+1(800)803-6025
customercare@trividiahealth.com
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