DEVICE: LZI Oral Fluid Collectors (B076S0000B1)

Device Identifier (DI) Information

LZI Oral Fluid Collectors
S0000b
In Commercial Distribution
S0000b
LIN-ZHI INTERNATIONAL, INC.
B076S0000B1
HIBCC

50
840839190 *Terms of Use
High-density polypropylene (HDPE) 50 mL centrifuge tubes.
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38868 Drug-testing specimen collection kit IVD
A covered receptacle and other associated materials/tools, available for use in the home and clinical settings, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other in vitro diagnostic investigation. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LAS Drug Specific Control Materials
DLJ Calibrators, Drug Specific
LAF Gas Chromatography, Methamphetamine
DKZ Enzyme Immunoassay, Amphetamine
DJG Enzyme Immunoassay, Opiates
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131652 000
K131653 000
K141205 000
K141320 000
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

ff6646b8-cff0-4c53-a409-56526607fe64
July 22, 2021
5
July 07, 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

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

[?]
Unit of Use DI Number: B076S0000B0 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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