FDA UDI
In Commercial Distribution
🇺🇸 United States
On Call Express Glucose Control Solution Kit
DI: 00682607557325
·
Model: G125-12D
·
ACON LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- On Call Express Glucose Control Solution Kit
- Primary DI
- 00682607557325
- Version / Model
- G125-12D
- Company Name
- ACON LABORATORIES, INC.
- Labeler DUNS
- 781100966
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c439171a-8989-45a5-b83f-736ba41bcafc
Device Description
Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| JJX | Single (specified) analyte controls (assayed and unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30854 | Home-use/point-of-care blood glucose monitoring system IVD | 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 together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10682607557322 | GS1 | case | 24 | In Commercial Distribution | |
| Primary | 00682607557325 | GS1 | ||||
| Package | 20682607557329 | GS1 | carton | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)838-9502 ext. 1
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132086 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 86 Degrees Fahrenheit