FDA UDI
In Commercial Distribution
🇺🇸 United States
TechLITE® Lancets
DI: 00015482880125
·
Model: 880125
·
ARKRAY USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- TechLITE® Lancets
- Primary DI
- 00015482880125
- Version / Model
- 880125
- Company Name
- ARKRAY USA, INC.
- Labeler DUNS
- 008171162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 1
- Public Version Date
- 2018-10-25
- Public Version Status
- New
- Public Device Record Key
- c52e624d-45fe-424f-81b1-7dbee614abe1
Device Description
TechLITE Lancets 25g 100's. Load lancet into lancing device and twist off protective cap. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. (Primary UPC# 015482880125; Shipper UPC# 015482882549 are used as the assigned UDI for the Class I device.)
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMK | Lancet, Blood | 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 | 00015482882549 | GS1 | Shipper Carton | 24 | In Commercial Distribution | |
| Primary | 00015482880125 | GS1 | ||||
| Unit of Use | 50015482880120 | GS1 |
Customer Contacts
- Phone
- 1-800-566-8558
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 25 | Gauge |