FDA UDI
In Commercial Distribution
🇺🇸 United States
GlucoLeader Enhance Blood Glucose Monitoring System(BR/IQ)
DI: 04711200722246
·
Model: 3K-01-140108
·
HMD BIOMEDICAL INC.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GlucoLeader Enhance Blood Glucose Monitoring System(BR/IQ)
- Primary DI
- 04711200722246
- Version / Model
- 3K-01-140108
- Catalog Number
- 3K-01-140108
- Company Name
- HMD BIOMEDICAL INC.
- Labeler DUNS
- 658644174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-11
- Public Version
- 3
- Public Version Date
- 2026-04-13
- Public Version Status
- Update
- Public Device Record Key
- 8337a70e-aca2-4f58-a201-4b1fa2214703
Device Description
GlucoLeader Enhance P5 Blood Glucose Monitoring System (BR/IQ)
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 53303 | Glucose IVD, kit, electrometry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included). | 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 | 04711200722246 | GS1 | ||||
| Package | 00389154000891 | GS1 | KIT | 216 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182428 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 8 – 44 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 46.6 – 111.2 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 70 Percent (%) Relative Humidity