Identity
- Trade Name
- GuruNanda Water Flosser R3100A FDA UDI
- Generic Name
- Oral lavage system FDA UDI
- Device Name
- Device R3100A 4.0 + 6 CMW Pods FDA UDI
- Model / Reference
- R3100A 4.0 FDA UDI
- Description
- Device R3100A 4.0 + 6 CMW Pods FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810051086515 FDA UDI
- FDA Product Code
- EFS FDA UDI
- GMDN Term
- Oral lavage system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6510 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oral lavage system
GuruNanda Water Flosser R3100A by Gurunanda Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral lavage system.
- Waterpik Aquarius Professional Water Flosser — WATER PIK, INC. · Class I
- Waterpik Cordless Freedom Water Flosser — WATER PIK, INC. · Class I
- Waterpik UltraPlus and Cordless Express Water Flosser — WATER PIK, INC. · Class I
- Waterpik Cordless Enhance Water Flosser — WATER PIK, INC. · Class I
- Sejoy Oral Irrigator — JOYTECH HEALTHCARE CO., LTD · Class I
- Waterpik Cordless Water Flosser — WATER PIK, INC. · Class I
- Waterpik Ultra Plus Water Flosser — WATER PIK, INC. · Class I
- HealthSmart — DMS HOLDINGS, INC., · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gurunanda Llc
Sources (1)
- FDA UDI 298e5fd0-7e74-4886-852c-9b7ae027e026 33 fields · synced May 30, 2026