FDA UDI
In Commercial Distribution
🇺🇸 United States
Curo A1c Analyzer
DI: 00860394001270
·
Model: Curo A1c Analyzer
·
KPI HEALTHCARE, INC.
Product Codes
2
GMDN Terms
10
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Curo A1c Analyzer
- Primary DI
- 00860394001270
- Version / Model
- Curo A1c Analyzer
- Company Name
- KPI HEALTHCARE, INC.
- Labeler DUNS
- 087243403
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-26
- Public Version
- 3
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 613c72ec-3e04-4be6-8d57-b99f2533d1b4
Device Description
Curo A1c Analyzer
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | Clinical Chemistry | 862.1345 | 2 |
| LCP | Assay, Glycosylated Hemoglobin | Hematology | 864.7470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60770 | Ambulatory insulin infusion pump/interstitial glucose monitoring system | An assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity. | 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 |
| 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 |
| 63088 | Blood glucose/blood pressure monitoring system, point-of-care | A collection of devices 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. 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 |
| 62645 | Glucose analyser IVD, home-use | An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; 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. This analyser is typically included in a blood glucose monitoring system. | No | Active |
| 44206 | Glucose analyser IVD, laboratory, automated | A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood, serum, plasma and/or other body fluid. The device operates with minimal technician involvement and complete automation of all procedural steps. | No | Obsolete |
| 62739 | Glucose analyser IVD, laboratory, manual | An electrically-powered manual laboratory instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood, serum, plasma and/or other body fluid. | No | Active |
| 56686 | Glucose analyser IVD, laboratory, automated/semi-automated | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood, serum, plasma and/or other body fluid. | No | Active |
| 62646 | Glucose analyser IVD, point-of-care | An electrically-powered instrument intended to be used exclusively at the point-of-care by medical professionals for the quantitative in vitro measurement of glucose levels in whole blood. 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 |
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00860394001270 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082275 | 000 |