Identity
- Trade Name
- LANZO Lancing Device FDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Device Name
- A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device. FDA UDI
- Model / Reference
- 570015 FDA UDI
- Description
- A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00015482570156 FDA UDI
- FDA Product Code
- FMK 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual blood lancing device, reusable
LANZO Lancing Device by Arkray Usa, Inc. — 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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- 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
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
- Arkray Usa, Inc.
Sources (1)
- FDA UDI 70e889e2-450d-4d88-8a19-b5cea240a408 34 fields · synced May 30, 2026