Identity
- Trade Name
- Hydrodebrider® FDA UDI
- Generic Name
- Nasal lavage system FDA UDI
- Device Name
- CONSOLE 1913001 HYDRODEBRIDER ROHS FDA UDI
- Model / Reference
- 1913001 FDA UDI
- Description
- CONSOLE 1913001 HYDRODEBRIDER ROHS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169360877 FDA UDI
- FDA Product Code
- KMA FDA UDI
- GMDN Term
- Nasal lavage system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.5550 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nasal lavage system
Hydrodebrider® by Medtronic Xomed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal lavage system.
- Naväge — Rhinosystems, Inc. · Class II
- Naväge — Rhinosystems, Inc. · Class II
- GuruNanda Portable Nasal Irrigator — GURUNANDA LLC · Class I
- iHealth — IHEALTH LAB INC. · Class I
- XTREME — Xtreme Personal Care Inc. · Class I
- SinuPulse — HEALTH SOLUTIONS MEDICAL PRODUCTS, CORP. · Class I
- SinuPulse — HEALTH SOLUTIONS MEDICAL PRODUCTS, CORP. · Class I
- iHealth — IHEALTH LAB 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
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI df0c28f8-cb00-4ceb-aee7-6b9687c93477 35 fields · synced May 30, 2026