DEVICE: H.E.B (00041220961689)

Device Identifier (DI) Information

H.E.B
Digital Pregnancy Test
In Commercial Distribution

H. E. BUTT GROCERY COMPANY
00041220961689
GS1

2
007924756 *Terms of Use
CB8 Digital Pregnancy Stick HEB DPS Digital Early US
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.
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FDA Product Code

[?]
Product Code Product Code Name
LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K060128 000
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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 30 Degrees Celsius
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Clinically Relevant Size

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

efabcd42-9b53-4de1-9c62-24adf4210a5e
July 06, 2018
3
August 23, 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
10041220961686 24 00041220961689 2017-03-31 Not in Commercial Distribution Shipping Case
00241220961683 24 00041220961689 In Commercial Distribution Shipping 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: 00633472000041 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-899-7353
xx@xx.xx
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