Identity
- Trade Name
- OneTouch Delica Plus Lancet FDA UDI
- Generic Name
- Blood lancing device tip FDA UDI
- Device Name
- Bag of 10 sterile lancets 30 Gauge FDA UDI
- Model / Reference
- 013-027 FDA UDI
- Description
- Bag of 10 sterile lancets 30 Gauge FDA UDI
Identifiers
- Catalog Number
- OTDP Lancet Bag 30g US/CA FDA UDI
- Primary DI / UDI-DI
- 00812608030040 FDA UDI
- 510(k) Number
- K221546 FDA UDI
- FDA Product Code
- QRK FDA UDI
- GMDN Term
- Blood lancing device tip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 30 Gauge FDA UDI
Category: Blood lancing device tip
OneTouch Delica Plus Lancet by Asahi Polyslider Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood lancing device tip.
- CareLiving — CARE LIVING DIAGNOSTICS INC · Class II
- PremierPro Lancet — SVS LLC · Class II
- FondCircle — FondCircle Inc. · Class II
- Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II
- metene — Tianjin Huahong Technology Co., Ltd. · Class II
- Care Touch — Tianjin Huahong Technology Co., Ltd. · Class II
- H.E.B. inControl — H. E. BUTT GROCERY COMPANY · Class II
- Accu-Chek Safe-T-Pro — ROCHE DIABETES CARE, INC. · Class II
Cleared under the same submission
K221546 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Asahi Polyslider Co., Ltd.
Sources (1)
- FDA UDI 46ea8e18-f762-4034-ba74-2196d78b883c 37 fields · synced Jun 6, 2026