Identity
- Trade Name
- HYDROCLEANSE™ FDA UDI
- Generic Name
- Nasal irrigation set, clinical FDA UDI
- Device Name
- DEVICE 1960100 SINUS WASH SYSTEM FDA UDI
- Model / Reference
- 1960100 FDA UDI
- Description
- DEVICE 1960100 SINUS WASH SYSTEM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169864429 FDA UDI
- FDA Product Code
- KAR FDA UDI
- GMDN Term
- Nasal irrigation set, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nasal irrigation set, clinical
Hydrocleanse™ by Medtronic Xomed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal irrigation set, clinical.
- Cyclone — Stryker Corp. · 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 |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI 689f482c-94bb-42c3-a5ca-57f8bc2e5c8a 34 fields · synced May 30, 2026