FDA UDI
In Commercial Distribution
🇺🇸 United States
Eocene
DI: 00854067005191
·
Model: EHS-SDMK-BT
·
VALUE PROVIDERS LLC
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Eocene
- Primary DI
- 00854067005191
- Version / Model
- EHS-SDMK-BT
- Company Name
- VALUE PROVIDERS LLC
- Labeler DUNS
- 079213227
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-02
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 05f5d4fd-6a7f-451f-97d9-f37cdfdcc7fa
Device Description
Smart Diabetes Bluetooth Glucose Monitor
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
| CGA | Glucose Oxidase, Glucose | Clinical Chemistry | 862.1345 | 2 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63086 | Glucose rapid test/blood pressure system analyser, point-of-care | A portable, electrically-powered instrument used with other devices (e.g., reagents, test strips, a blood pressure cuff, and accessories) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose levels in whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure. The measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system. | No | Active |
| 63087 | Blood glucose/blood pressure monitoring system, home-use | A collection of devices intended for the quantitative measurement of glucose levels in whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854067005191 | GS1 |
Customer Contacts
- Phone
- (321) 567-0688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111456 | 000 |