DEVICE: Care One (00041520113429)

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Device Record History
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Device Identifier (DI) Information
Care One
055544
In Commercial Distribution

Ahold U.S.A., Inc.
00041520113429
GS1

1
170199058 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
No
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?
46994 Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test 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
NQQ System, Imaging, Optical Coherence Tomography (Oct)
NFT Test, Amphetamine, Over The Counter
PTH Test, Barbiturate, Over The Counter
NFV Test, Benzodiazepine, Over The Counter
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter
NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
PTG Test, Methadone, Over The Counter
NGM Test, Phencyclidine (Pcp), Over The Counter
QAW Test, Tricyclic Antidepressants, Over The Counter
LDJ Enzyme Immunoassay, Cannabinoids
LCM Enzyme Immunoassay, Phencyclidine
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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
99175053-466b-4701-b74d-aae98d5f1da1
June 10, 2022
2
August 26, 2021
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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
10041520113426 1 00041520113429 In Commercial Distribution
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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

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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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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