DEVICE: Walgreens (00311917034201)

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Device Record History
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Device Identifier (DI) Information
Walgreens
765422
In Commercial Distribution

WALGREEN CO.
00311917034201
GS1

1
008965063 *Terms of Use
4 Drugs Tested Home Drug Test - THC50/COC300/MET1000/OPI2000
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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?
55553 Cannabinoid/cannabinoid metabolite IVD, reagent
A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen.
Active false
55570 Cocaine/cocaine metabolite IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cocaine and/or cocaine metabolites in a clinical specimen.
Active false
55501 Methamphetamine-specific IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of a specific methamphetamine in a clinical specimen.
Active false
55724 Opiate/opiate metabolite IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NFW Test, Cannabinoid, Over The Counter
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter
NGG Test, Methamphetamine, Over The Counter
NGL Test, Opiates, Over The Counter
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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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
0a6c4b5b-b74f-42be-bf82-c456c81f9b5c
July 19, 2023
1
July 11, 2023
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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
10311917034208 12 00311917034201 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

[?]
1-800-925-4733
consumerrelations.pq@walgreens.com
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