DEVICE: Prodigy Voice Blood Glucose Monitoring System (00384840719507)
Device Identifier (DI) Information
Prodigy Voice Blood Glucose Monitoring System
071950
In Commercial Distribution
071950
Prodigy Diabetes Care, LLC
071950
In Commercial Distribution
071950
Prodigy Diabetes Care, LLC
Prodigy Voice Blood Glucose Monitoring System (KIT)
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? |
|---|---|---|---|---|
| 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 |
| 41819 | Glucose IVD, control |
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.
|
Active | 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 |
| 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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FMK | Lancet, Blood |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| FMI | Needle, Hypodermic, Single Lumen |
| 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
6cde2882-1edb-46f9-b866-8b145cb47d9b
September 27, 2023
3
September 22, 2016
September 27, 2023
3
September 22, 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 |
|---|---|---|---|---|---|
| 00384843719504 | 10 | 00384840719507 | In Commercial Distribution | Corrugated 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
[?]
No Customer Contact currently defined