FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00812277030037
·
Model: 2763-32703
·
BOUND TREE MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00812277030037
- Version / Model
- 2763-32703
- Catalog Number
- 2763-32703
- Company Name
- BOUND TREE MEDICAL, LLC
- Labeler DUNS
- 070556204
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-15
- Public Version
- 2
- Public Version Date
- 2019-08-09
- Public Version Status
- Update
- Public Device Record Key
- c8c63945-bb06-4cf5-809e-ac65c2a466f5
Device Description
Curaplex Blood Glucose Test Strips 50/BX
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 |
|---|---|---|---|---|
| CGA | GLUCOSE OXIDASE, GLUCOSE | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 | 00812277030044 | GS1 | BOX | 2 | In Commercial Distribution | |
| Primary | 00812277030037 | GS1 | ||||
| Package | 00812277030051 | GS1 | CASE | 270 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082965 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 32 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY; KEEP AWAY FROM DIRECT SUNLIGHT