FDA UDI
In Commercial Distribution
🇺🇸 United States
GLUCOCARD® W Blood Glucose Monitoring System
DI: 00015482511104
·
Model: 511100
·
ARKRAY USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GLUCOCARD® W Blood Glucose Monitoring System
- Primary DI
- 00015482511104
- Version / Model
- 511100
- Company Name
- ARKRAY USA, INC.
- Labeler DUNS
- 008171162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-01
- Public Version
- 1
- Public Version Date
- 2019-04-09
- Public Version Status
- New
- Public Device Record Key
- 52e8e01e-f180-417e-ba0c-8083854e082a
Device Description
The GLUCOCARD W Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the palm. For single-patient use only.
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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10015482511101 | GS1 | Case Shipper | 4 | In Commercial Distribution | |
| Primary | 00015482511104 | GS1 |
Customer Contacts
- Phone
- 1-800-566-8558
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170064 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit