Identity
- Trade Name
- Irrimax FDA UDI
- Generic Name
- Non-antimicrobial wound irrigation solution, saline FDA UDI
- Device Name
- Irrimax Wound Irrigation System FDA UDI
- Model / Reference
- Max-101 FDA UDI
- Description
- Irrimax Wound Irrigation System FDA UDI
Identifiers
- Catalog Number
- 0002 FDA UDI
- Primary DI / UDI-DI
- 10842351100025 FDA UDI
- FDA Product Code
- KYZ FDA UDI
- GMDN Term
- Non-antimicrobial wound irrigation solution, saline FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6960 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 450 Milliliter FDA UDI
Irrimax by Irrimax Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Irrimax Corporation
Sources (1)
- FDA UDI 99cec28b-9dd1-44fa-b312-b045385dabd7 38 fields · synced May 31, 2026