DEVICE: TRUEplus (00021292008178)

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Device Record History
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Device Identifier (DI) Information
TRUEplus
TRUEplus Ketone Test Strips
In Commercial Distribution

TRIVIDIA HEALTH, INC.
00021292008178
GS1

50
151810868 *Terms of Use
TRUEplus Ketone Test Strips
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
54519 Urine ketone IVD, kit, rapid colorimetric, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for ketones within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
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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: less than 86 Degrees Fahrenheit
Special Storage Condition, Specify: DO NOT REFRIGERATE OR FREEZE
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
bd0c7872-3ba1-42d1-a4b3-7677aeebdb9e
November 28, 2022
2
October 21, 2020
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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
00311917173900 2 00021292008178 In Commercial Distribution BOX
00021292001469 1 00021292008178 In Commercial Distribution BOX
00041260007378 1 00021292008178 In Commercial Distribution BOX
10041260007375 48 00041260007378 In Commercial Distribution CASE
10021292001466 48 00021292001469 In Commercial Distribution CASE
10311917173907 24 00311917173900 In Commercial Distribution CASE
00719283278104 2 00021292008178 In Commercial Distribution BOX
10311917203383 48 00311917203386 In Commercial Distribution CASE
00311917203386 1 00021292008178 In Commercial Distribution BOX
00708820514577 1 00021292008178 In Commercial Distribution BOX
00311917108735 1 00021292008178 In Commercial Distribution BOX
10311917108732 48 00311917108735 In Commercial Distribution CASE
10050428615277 48 00050428615270 In Commercial Distribution CASE
00050428615270 1 00021292008178 In Commercial Distribution BOX
00050428371107 2 00021292008178 In Commercial Distribution BOX
10708820514574 48 00708820514577 In Commercial Distribution CASE
10021292012530 24 00021292012533 In Commercial Distribution CASE
00021292012533 2 00021292008178 In Commercial Distribution BOX
10011822362396 48 00011822362399 In Commercial Distribution CASE
00011822362399 1 00021292008178 In Commercial Distribution BOX
10050428371104 24 00050428371107 In Commercial Distribution CASE
10719283278101 24 00719283278104 In Commercial Distribution CASE
00050428312957 1 00021292008178 In Commercial Distribution BOX
10050428312954 48 00050428312957 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: 00021292007768 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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