| Primary Device ID | 00384841518505 |
| NIH Device Record Key | 70e790d7-835c-4861-85a2-0ffeafdf2666 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prodigy AutoCode Blood Glucose Monitoring System |
| Version Model Number | 051885 |
| Catalog Number | 051885 |
| Company DUNS | 832875905 |
| Company Name | PRODIGY DIABETES CARE, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384840518858 [Primary] |
| GS1 | 00384840701205 [Primary] |
| GS1 | 00384840743007 [Primary] |
| GS1 | 00384841518505 [Direct Marking] |
| GS1 | 00384843518855 [Package] Contains: 00384840518858 Package: Corrugated Carton [10 Units] In Commercial Distribution |
| GS1 | 00384843701202 [Package] Contains: 00384840701205 Package: Corrugated Carton [10 Units] In Commercial Distribution |
| GS1 | 00384843743004 [Package] Contains: 00384840743007 Package: Corrugated Box [10 Units] In Commercial Distribution |
| NDC/NHRIC | 08484-0743-00 [Secondary] |
| CGA | Glucose Oxidase, Glucose |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-21 |
| 00384841518505 | Prodigy AutoCode Blood Glucose Monitoring System (Meter Only) |
| 00038481518505 | Prodigy AutoCode Blood Glucose Monitoring System (KIT) |