Identity
- Trade Name
- PremierPro Lancet FDA UDI
- Generic Name
- Blood lancing device tip FDA UDI
- Device Name
- Description: Lancet, Push Button, 28G x 1.5mm, Purple Instructions for use 1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site and press the push-button to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings 1. Do not use if protective cap has been previously removed from lancet. 2. Clean the injection site prior to use following established procedure. 3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations. FDA UDI
- Model / Reference
- 7573 FDA UDI
- Description
- Description: Lancet, Push Button, 28G x 1.5mm, Purple Instructions for use 1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site and press the push-button to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings 1. Do not use if protective cap has been previously removed from lancet. 2. Clean the injection site prior to use following established procedure. 3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations. FDA UDI
Identifiers
- Catalog Number
- 7573 FDA UDI
- Primary DI / UDI-DI
- 00811220030407 FDA UDI
- FDA Product Code
- FMK 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood lancing device tip
PremierPro Lancet by Svs Llc — 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
- 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
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Svs Llc
Sources (1)
- FDA UDI 01536ee1-7de1-42f2-8ffb-c43491dcdf3e 36 fields · synced May 30, 2026