DEVICE: On Call Express II Glucose Monitoring System (00682607571079)

Device Identifier (DI) Information

On Call Express II Glucose Monitoring System
G117-10A
In Commercial Distribution
757107
Acon Laboratories, Inc.
00682607571079
GS1

1
781100966 *Terms of Use
Blood Glucose Meter, 10 test strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62537 Glucose monitoring system IVD, home-use
A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NBW System, test, blood glucose, over the counter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K192175 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 41 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Store in a cool, dry place at 10-90% Relative Humidity. Keep out of direct sunlight.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

fe23e44f-854c-464d-a33f-0b30d2253be5
June 20, 2025
3
December 16, 2019
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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
10682607571076 4 00682607571079 In Commercial Distribution Case
20682607571073 6 10682607571076 In Commercial Distribution Carton
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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
Yes
00682607001675
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)838-9502 1
support@aconlabs.com
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