Identity
- Trade Name
- One +Step FDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Model / Reference
- LDE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06949517008878 FDA UDI
- 510(k) Number
- K222472 FDA UDI
- FDA Product Code
- QRL 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
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
Yes
FDA UDI
Category: Manual blood lancing device, reusable
One +Step by Shandong Lianfa Medical Plastic Products CO., LTD — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Manual blood lancing device, reusable.
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- Autolet — OWEN MUMFORD USA INCORPORATED · 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
- Medtlet — Carelife (usa) Inc. · Class II
Cleared under the same submission
K222472 also covers:
- THERA Plus — FOURSTAR GROUP INC.
- THERA Plus — FOURSTAR GROUP INC.
- EasyTouch — MHC Medical Products
- EasyTouch — MHC Medical Products
- EasyTouch — MHC Medical Products
- EasyTouch — MHC Medical Products
- EasyTouch — MHC Medical Products
- One +Step — Shandong Lianfa Medical Plastic Products CO., LTD
- One +Step — Shandong Lianfa Medical Plastic Products CO., LTD
- One +Step — Shandong Lianfa Medical Plastic Products CO., LTD
- One +Step — Shandong Lianfa Medical Plastic Products CO., LTD
- Twist Lancet(30G) — Shandong Lianfa Medical Plastic Products CO., LTD
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 |
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Manufacturer
- Manufacturer
- Shandong Lianfa Medical Plastic Products CO., LTD
Sources (1)
- FDA UDI f825bf8d-99fc-4755-88e9-fa05ac21b8a6 33 fields · synced May 30, 2026