Identity
- Trade Name
- OneTouch Delica Plus Lancing Device FDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Device Name
- Box of 1 Lancing Device and 10 Sterile Lancets 30 Gauge FDA UDI
- Model / Reference
- 02397301 FDA UDI
- Description
- Box of 1 Lancing Device and 10 Sterile Lancets 30 Gauge FDA UDI
Identifiers
- Catalog Number
- OTDP Lancing Device US FDA UDI
- Primary DI / UDI-DI
- 00812608030057 FDA UDI
- 510(k) Number
- K221546 FDA UDI
- FDA Product Code
- QRL FDA UDIQRK FDA UDI
- GMDN Term
- Manual blood lancing device, reusable 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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 tipManual blood lancing device, reusable
OneTouch Delica Plus Lancing Device by Asahi Polyslider Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual blood lancing device, reusable.
- Pylo Health — PREVOUNCE HEALTH, INC · Class II
- Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II
- BEWELL CONNECT MyGluco Lancing device — Visiomed Group SA · Class II
- Autolet — OWEN MUMFORD USA INCORPORATED · Class II
- Lancing Device — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- TeleRPM & Chronica — Mio Labs Inc.
- Accu-Chek Safe-T-Pro — ROCHE DIABETES CARE, INC. · Class II
- Accu-Chek Fastclix — 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 60b57cde-2967-47ef-bff3-343b0d77a3ae 37 fields · synced May 31, 2026