FDA UDI
In Commercial Distribution
🇺🇸 United States
ONE-CARE
DI: 00810008210048
·
Model: AC500 PRO
·
MediVena, LLC
Product Codes
1
GMDN Terms
2
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ONE-CARE
- Primary DI
- 00810008210048
- Version / Model
- AC500 PRO
- Catalog Number
- 4002
- Company Name
- MediVena, LLC
- Labeler DUNS
- 080740980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-10
- Public Version
- 1
- Public Version Date
- 2023-09-18
- Public Version Status
- New
- Public Device Record Key
- 4812174f-1d0b-487d-9f0e-0baf34a040f0
Device Description
ONE-CARE PRO test strips are intended for use with ONE-CARE PRO glucose meters for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE PRO system can be used by healthcare professionals in multi-patient setting or at home (over the counter OTC) by persons with diabetes. Test strips require small blood samples size of 0.5ul to provide accurate and fast results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
| 62538 | Glucose monitoring system IVD, point-of-care | A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. 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 |
|---|---|---|---|---|---|---|
| Package | 00810008210499 | GS1 | inner pack | 280 | In Commercial Distribution | |
| Primary | 00810008210048 | GS1 | ||||
| Package | 00810008210505 | GS1 | case | 560 | In Commercial Distribution |
Customer Contacts
- Phone
- 404-514-2586
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 86 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit