Identity
- Trade Name
- Pylo Health FDA UDI
- Generic Name
- Manual blood lancing device, reusable FDA UDI
- Device Name
- Pylo Lancing Device FDA UDI
- Model / Reference
- GL1-LCT FDA UDI
- Description
- Pylo Lancing Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011521235 FDA UDI
- 510(k) Number
- K220475 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
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
Yes
FDA UDI
Category: Manual blood lancing device, reusable
Pylo Health by Prevounce Health, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual blood lancing device, reusable.
- 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
- Medtlet — Carelife (usa) Inc. · Class II
Cleared under the same submission
K220475 also covers:
- TechLITE® Lancets, 26g — ARKRAY USA, INC.
- TechLITE® Lancets, 28g — ARKRAY USA, INC.
- Greater Goods — Greater Goods, LLC
- Pylo Health — PREVOUNCE HEALTH, INC
- GLUCOPAD TC-SMART+ Lancets Kit — TECO DIAGNOSTICS
- CareSens — i-SENS, Inc.
- CareSens — i-SENS, Inc.
- CareSens — i-SENS, Inc.
- Tempo — i-SENS, Inc.
- Tempo — i-SENS, Inc.
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
- Prevounce Health, Inc
Sources (1)
- FDA UDI 479c0535-8289-4244-8c23-d408c27ad550 34 fields · synced Jun 8, 2026