FDA UDI
In Commercial Distribution
🇺🇸 United States
Nipro Twist Lancet
DI: 00383790011655
·
Model: DK-LANCET30100
·
NIPRO MEDICAL CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Nipro Twist Lancet
- Primary DI
- 00383790011655
- Version / Model
- DK-LANCET30100
- Company Name
- NIPRO MEDICAL CORPORATION
- Labeler DUNS
- 797372554
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-01-13
- Public Version
- 1
- Public Version Date
- 2023-01-23
- Public Version Status
- New
- Public Device Record Key
- fb3f0c68-6007-4629-96e1-2305043fd8fa
Device Description
Disposable Sterile Lancets - 30G
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 |
|---|---|---|---|---|
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | General, Plastic Surgery | 878.4850 | 2 |
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00383790011648 | GS1 | ||||
| Primary | 00383790011655 | GS1 | ||||
| Package | 00383790011662 | GS1 | Case | 200 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 30 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- The products should be stored in a well-ventilated room and kept away from light, moisture and corrosive gases.