DEVICE: H-E-B inControl (00041220865468)

Device Identifier (DI) Information

H-E-B inControl
G20
In Commercial Distribution

H. E. BUTT GROCERY COMPANY
00041220865468
GS1

50
007924756 *Terms of Use
Blood Glucose Test Strips
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
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
Glucose IVD, kit, electrometry A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.
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FDA Product Code

[?]
Product Code Product Code Name
CGA Glucose Oxidase, Glucose
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092099 000
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

106af2a7-fdb1-4972-939d-a1cc385000e2
July 06, 2018
3
December 13, 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: 80816042012873 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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