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.
G117-10A
In Commercial Distribution
757107
Acon Laboratories, Inc.
Blood Glucose Meter, 10 test strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NBW | System, test, blood glucose, over the counter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K192175 | 000 |
Sterilization
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. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
fe23e44f-854c-464d-a33f-0b30d2253be5
June 20, 2025
3
December 16, 2019
June 20, 2025
3
December 16, 2019
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)838-9502
1
support@aconlabs.com
support@aconlabs.com