FDA UDI
In Commercial Distribution
🇺🇸 United States
ODM
DI: 00883489001504
·
Model: iGlucose Blood Glucose Monitoring System
·
BIONIME CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
9
Pkg Device Count
1
Basic Information
- Brand Name
- ODM
- Primary DI
- 00883489001504
- Version / Model
- iGlucose Blood Glucose Monitoring System
- Catalog Number
- 99GM291I01
- Company Name
- BIONIME CORPORATION
- Labeler DUNS
- 658637244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-19
- Public Version
- 4
- Public Version Date
- 2020-01-06
- Public Version Status
- Update
- Public Device Record Key
- 24bd8864-462f-451d-80ea-dc478ffab99e
Device Description
The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control solution(00883489001580),10 pcs/set of lancet(Sterile)(00883489001597) and 10 pcs/vial of strips_iGlucose Strip(00883489001573).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- 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
- No
- Has Manufacturing Date
- Yes
- 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 |
| CGA | Glucose Oxidase, Glucose | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62537 | Glucose monitoring system IVD, home-use | A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; 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. 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 | 00883489001504 | GS1 | ||||
| Package | 00883489001580 | GS1 | combo | 1 | In Commercial Distribution | |
| Package | 00883489001573 | GS1 | combo | 10 | In Commercial Distribution | |
| Package | 00883489001566 | GS1 | combo | 1 | In Commercial Distribution | |
| Package | 00883489001511 | GS1 | box | 1 | In Commercial Distribution | |
| Package | 20883489001515 | GS1 | carton | 40 | Not in Commercial Distribution | 2020-01-03 |
| Package | 00883489001597 | GS1 | combo | 10 | In Commercial Distribution | |
| Package | 10883489001518 | GS1 | paper box | 6 | In Commercial Distribution | |
| Package | 20883489001508 | GS1 | paper carton | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-844-445-8267
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161790 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Meter Dimensions 104 mm × 49.8 mm × 16.5 mm |