| Primary Device ID | 00853483008137 | 
| NIH Device Record Key | 4d219bfe-3554-47fd-8f05-3d93659996aa | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | VivaGuard | 
| Version Model Number | VGL02 | 
| Catalog Number | VGL02-382 | 
| Company DUNS | 080952036 | 
| Company Name | Able Diagnostics Inc | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | true | 
| 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 | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00853483008137 [Primary] | 
| FMK | Lancet, Blood | 
| Steralize Prior To Use | true | 
| Device Is Sterile | true | 
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
[00853483008137]
Radiation Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-02-17 | 
| Device Publish Date | 2021-02-09 | 
| 00853483008144 | VivaGuard Lancets 100s (30G) | 
| 00853483008137 | VivaGuard Safety Lancets (100s) | 
| 00853483008038 | VivaGuard Lancing Device | 
| 00853483008021 | VivaGuard Lancets 50s (30G) | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() VIVAGUARD  87651114  5625412 Live/Registered  | 
        Able Diagnostics, Inc.  2017-10-18  | 
![]() VIVAGUARD  79313858  not registered Live/Pending  | 
        VivaChek Biotech (Hangzhou) Co., Ltd.  2021-02-18  | 
![]() VIVAGUARD  78354369  not registered Dead/Abandoned  | 
        Novus International, Inc.  2004-01-20  | 
![]() VIVAGUARD  78091165  not registered Dead/Abandoned  | 
        Eastman Chemical Company  2001-11-01  | 
![]() VIVAGUARD  75935833  not registered Dead/Abandoned  | 
        Novus International, Inc.  2000-03-06  |