Identity
- Trade Name
- SinuPulse FDA UDI
- Generic Name
- Nasal lavage system FDA UDI
- Device Name
- SinuPulse Nasal Irrigation FDA UDI
- Model / Reference
- SPT300 FDA UDI
- Description
- SinuPulse Nasal Irrigation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00892773001199 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
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
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: Nasal lavage system
SinuPulse by Health Solutions Medical Products, Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Nasal lavage system.
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- Hydrodebrider® — MEDTRONIC XOMED, INC. · Class I
- Hydrodebrider® — MEDTRONIC XOMED, INC. · 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 |
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Manufacturer
- Manufacturer
- Health Solutions Medical Products, Corp.
Sources (1)
- FDA UDI 0d5ea6bf-9cb1-4b34-a1bc-b90653e7e3a9 34 fields · synced May 31, 2026