DEVICE: AgaMatrix (00385541002103)
Device Identifier (DI) Information
AgaMatrix
8000-10473
In Commercial Distribution
AGAMATRIX, INC.
8000-10473
In Commercial Distribution
AGAMATRIX, INC.
Test Strips, AgaMatrix, Jazz, 50CT
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
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.
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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 [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between 46 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
2d727783-488b-4ad7-8345-00111f72be9a
December 03, 2018
4
July 11, 2016
December 03, 2018
4
July 11, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10385541002407 | 12 | 00385541002301 | In Commercial Distribution | Shipper | |
00385541002301 | 2 | 00385541002103 | In Commercial Distribution | Carton | |
10385541002209 | 24 | 00385541002103 | In Commercial Distribution | Shipper | |
20385541003104 | 8 | 10385541002407 | In Commercial Distribution | Outer Shipper | |
20385541003005 | 20 | 10385541002209 | In Commercial Distribution | Outer Shipper |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
80385541002109
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
18669064197
customerservice@agamatrix.com
customerservice@agamatrix.com