FDA UDI
In Commercial Distribution
🇺🇸 United States
GLUCOCARD® 01 Control
DI: 00015482720056
·
Model: 720005
·
ARKRAY USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GLUCOCARD® 01 Control
- Primary DI
- 00015482720056
- Version / Model
- 720005
- Company Name
- ARKRAY USA, INC.
- Labeler DUNS
- 008171162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-01
- Public Version
- 1
- Public Version Date
- 2019-08-09
- Public Version Status
- New
- Public Device Record Key
- 81224ff0-c1d6-4798-b97e-b1e140b4f6a7
Device Description
GLUCOCARD 01 Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 015482720056 is used as the assigned UDI for the Class I device.)
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
- Yes
- 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 |
|---|---|---|---|---|
| 41819 | Glucose IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00015482720056 | GS1 |
Customer Contacts
- Phone
- 1-800-566-8558
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 34 – 86 Degrees Fahrenheit