DEVICE: Hydrocodone 100 DAU Control, Level 1 Control (B07603870)

Device Identifier (DI) Information

Hydrocodone 100 DAU Control, Level 1 Control
0387
In Commercial Distribution
0387
LIN-ZHI INTERNATIONAL, INC.
B07603870
HIBCC

1
840839190 *Terms of Use
5mL/bottle. Concentration: 75 ng/mL of Hydrocodone.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Opiate/opiate metabolite IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
LAS Drug Specific Control Materials
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141055 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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

dea95ef1-839b-4770-95eb-b2cca296c482
July 06, 2018
3
July 05, 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
No Package DIs found
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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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