FDA UDI
In Commercial Distribution
🇺🇸 United States
ONE-CARE
DI: 00810008210987
·
Model: AC500
·
MediVena, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ONE-CARE
- Primary DI
- 00810008210987
- Version / Model
- AC500
- Catalog Number
- 4010
- 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
- 01ed7702-63c7-424c-92a5-20e50151041a
Device Description
ONE-CARE Control Solution (Level 1 – Low and Level 3 - High) contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the ONE-CARE test strip bottle label.
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41819 | Glucose IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810008210994 | GS1 | inner pack | 450 | In Commercial Distribution | |
| Primary | 00810008210987 | GS1 | ||||
| Package | 00810008211007 | GS1 | case | 900 | 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