FDA UDI
In Commercial Distribution
🇺🇸 United States
Diska Nulife
DI: 00810115891710
·
Model: I
·
Diska LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Diska Nulife
- Primary DI
- 00810115891710
- Version / Model
- I
- Company Name
- Diska LLC
- Labeler DUNS
- 006311259
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2023-08-25
- Public Version
- 1
- Public Version Date
- 2023-09-04
- Public Version Status
- New
- Public Device Record Key
- ea329649-db06-4943-a838-70de0fa4c12f
Device Description
Single Use Lancets
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | General, Plastic Surgery | 878.4850 | 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 | 00810115891734 | GS1 | Case | 400 | In Commercial Distribution | |
| Primary | 00810115891710 | GS1 | ||||
| Unit of Use | 00810115891727 | GS1 |
Customer Contacts
- Phone
- 201-675-6037
- [email protected]