DEVICE: Prodigy Value Pack (00384840751507)
Device Identifier (DI) Information
Prodigy Value Pack
075150
In Commercial Distribution
075150
Prodigy Diabetes Care, LLC
075150
In Commercial Distribution
075150
Prodigy Diabetes Care, LLC
Prodigy Value Pack
12 x Item # 073200; 4 x Item # 07120
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 30854 | Home-use/point-of-care blood glucose monitoring system IVD |
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 together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
|
Obsolete | false |
| 53303 | 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.
|
Active | false |
| 37243 | Manual blood lancing device, reusable |
A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| CGA | Glucose Oxidase, Glucose |
| 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 |
|---|
| Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H. |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
9a9f6c83-f306-4f91-87ae-937afcb73082
September 27, 2023
3
September 21, 2016
September 27, 2023
3
September 21, 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 |
|---|---|---|---|---|---|
| No Package DIs found | |||||
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
[?]
No Customer Contact currently defined