FDA UDI
In Commercial Distribution
🇺🇸 United States
VivaGuard Ino
DI: 00853483008052
·
Model: VGM01
·
Able Diagnostics Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VivaGuard Ino
- Primary DI
- 00853483008052
- Version / Model
- VGM01
- Catalog Number
- VGM01-373
- Company Name
- Able Diagnostics Inc
- Labeler DUNS
- 080952036
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-02
- Public Version
- 1
- Public Version Date
- 2021-02-10
- Public Version Status
- New
- Public Device Record Key
- 083aec87-4ece-4590-ac51-893b1a01b8e5
Device Description
VivaGuard Ino Blood Glucose Meter Only Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853483008052 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160179 | 000 |