FDA UDI
In Commercial Distribution
🇺🇸 United States
MICROLET®
DI: 00301936586218
·
Model: 6586 / 6586W
·
ASCENSIA DIABETES CARE US INC.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
100
Basic Information
- Brand Name
- MICROLET®
- Primary DI
- 00301936586218
- Version / Model
- 6586 / 6586W
- Catalog Number
- 81264857, 81264954 (US)
- 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
- 2019-06-06
- Public Version
- 2
- Public Version Date
- 2022-11-22
- Public Version Status
- Update
- Public Device Record Key
- 55dfab27-fce9-4952-97fc-e7516661e22c
Device Description
Colored lancets. Silicone-coated lancets. Use with the MICROLET Family of lancing devices.
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
- No
- 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 |
|---|---|---|---|---|
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 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 | 40301936586124 | GS1 | shipper/case | 12 | In Commercial Distribution | |
| Primary | 00301936586218 | GS1 | ||||
| Package | 40301936586216 | GS1 | shipper/case | 24 | In Commercial Distribution | |
| Secondary | 0193-6586-21 | NDC/NHRIC | ||||
| Unit of Use | 00301936586010 | GS1 |
Customer Contacts
- Phone
- 800-348-8100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220633 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if protective cap has been previously removed. Do not reuse.