| Primary Device ID | 00840423500486 |
| NIH Device Record Key | 4ceb72af-516e-4081-b141-9b97d07df1e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VivaGuard Safety Lancets (18G) |
| Version Model Number | VGL02-2U5 |
| Catalog Number | VGL02-2U5 |
| Company DUNS | 119217208 |
| Company Name | ABOUND Diagnostics, Inc. |
| 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 | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com | |
| Phone | 8889696928 |
| lmariano@abounddiagnostics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840423500141 [Primary] |
| GS1 | 00840423500486 [Package] Contains: 00840423500141 Package: carton [50 Units] In Commercial Distribution |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-21 |
| Device Publish Date | 2025-04-11 |
| 00840423500684 - VivaGuard Ino Blood Glucose Test Strips | 2025-06-16 VivaGuard Ino Blood Glucose Test Strips |
| 00840423500691 - VivaGuard Ino Control Solution | 2025-06-16 VivaGuard Ino Control Solution |
| 00840423500707 - VivaGuard Ino Smart Blood Glucose Meter | 2025-06-16 VivaGuard Ino Smart Blood Glucose Meter |
| 00840423500004 - VivaGuard Ino Blood Glucose Meter | 2025-06-11 VivaGuard Ino Blood Glucose Meter |
| 00840423500516 - VivaGuard Lancets (21G) | 2025-04-21 VivaGuard Lancets (21G) |
| 00840423500509 - VivaGuard Lancets (23G) | 2025-04-21 VivaGuard Lancets (23G) |
| 00840423500400 - VivaGuard Lancets (26G) | 2025-04-21 VivaGuard Lancets (26G) |
| 00840423500103 - VivaGuard Lancets (28G) | 2025-04-21 VivaGuard Lancets (28G) |