Primary Device ID | 00840423500424 |
NIH Device Record Key | d718a5cf-929d-4a76-bab3-5b7ca2740943 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VivaGuard Lancing Device |
Version Model Number | VGD01-381 |
Catalog Number | VGD01-381 |
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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
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 |
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 | 00840423500134 [Primary] |
GS1 | 00840423500424 [Package] Contains: 00840423500134 Package: carton [400 Units] In Commercial Distribution |
QRL | Multiple Use Blood Lancet For Single Patient Use Only |
Steralize Prior To Use | false |
Device Is Sterile | false |
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) |