FDA UDI
In Commercial Distribution
🇺🇸 United States
OneTouch Delica Plus Lancet
DI: 00812608030217
·
Model: 02419901
·
ASAHI POLYSLIDER COMPANY,LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
Basic Information
- Brand Name
- OneTouch Delica Plus Lancet
- Primary DI
- 00812608030217
- Version / Model
- 02419901
- Catalog Number
- OTDP Lancet 30g 30 US
- Company Name
- ASAHI POLYSLIDER COMPANY,LIMITED
- Labeler DUNS
- 718296825
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2020-11-18
- Public Version
- 2
- Public Version Date
- 2022-09-28
- Public Version Status
- Update
- Public Device Record Key
- 412cd8ed-4bbd-4284-b0ea-6ec234dacaf4
Device Description
Box of 30 Sterile Lancets 30 Gauge
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 |
|---|---|---|---|---|
| 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 | 00812608030149 | GS1 | ||||
| Primary | 00812608030217 | GS1 | ||||
| Package | 20812608030211 | GS1 | Cardboard box | 240 | In Commercial Distribution |
Customer Contacts
- Phone
- 1 888 567-3003
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221546 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 30 | Gauge |