Identity
- Trade Name
- Greater Goods FDA UDI
- Generic Name
- Blood glucose/blood pressure monitoring system, home-use FDA UDI
- Device Name
- 0012 Blood Glucose Lancets FDA UDI
- Model / Reference
- 0012 FDA UDI
- Description
- 0012 Blood Glucose Lancets FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00875011000123 FDA UDI
- 510(k) Number
- K220475 FDA UDI
- FDA Product Code
- QRL FDA UDI
- GMDN Term
- Blood glucose/blood pressure monitoring system, home-use 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood glucose/blood pressure monitoring system, home-use
Greater Goods by Greater Goods, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood glucose/blood pressure monitoring system, home-use.
- Health Wealth Safe — Mio Labs Inc. · Class II
- owell — OWELL · Class II
- Eocene — VALUE PROVIDERS LLC · Class I
- owell — OWELL · Class II
- Health Wealth Safe — Mio Labs Inc. · Class II
- TeleRPM & Chronica — Mio Labs Inc.
- CURO L5 — KPI HEALTHCARE, INC. · Class II
- Active Forward — OWELL · Class II
Cleared under the same submission
K220475 also covers:
- TechLITE® Lancets, 26g — ARKRAY USA, INC.
- TechLITE® Lancets, 28g — ARKRAY USA, INC.
- Pylo Health — PREVOUNCE HEALTH, INC
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Greater Goods, LLC
Sources (1)
- FDA UDI 96285ce0-a662-423c-b248-eedabcc8c8d9 34 fields · synced May 30, 2026