FDA UDI
In Commercial Distribution
🇺🇸 United States
MICROLET® NEXT
DI: 00301936021214
·
Model: 6021
·
ASCENSIA DIABETES CARE US INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- MICROLET® NEXT
- Primary DI
- 00301936021214
- Version / Model
- 6021
- Catalog Number
- 90012282
- Company Name
- ASCENSIA DIABETES CARE US INC.
- Labeler DUNS
- 080028910
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2026-03-16
- Public Version
- 1
- Public Version Date
- 2026-03-24
- Public Version Status
- New
- Public Device Record Key
- fce0e9e4-4f89-47a7-800c-f41396c358f7
Device Description
Colored Lancets.
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | 878.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45142 | Blood lancing device tip | A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40301936021212 | GS1 | shipper/case | 12 | In Commercial Distribution | |
| Primary | 00301936021214 | GS1 | ||||
| Unit of Use | 20301936021218 | GS1 |
Customer Contacts
- Phone
- 800-348-8100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241810 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 28 | Gauge |