Identity
- Trade Name
- Irrisept Antimicrobial Wound Lavage FDA UDI
- Generic Name
- Pressure-regulated wound irrigation solution applicator, manual FDA UDI
- Device Name
- 450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator. FDA UDI
- Model / Reference
- ISEPT-500-INT FDA UDI
- Description
- 450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10842351110093 FDA UDI
- 510(k) Number
- K210536 FDA UDI
- FDA Product Code
- FQH FDA UDIFRO FDA UDI
- GMDN Term
- Pressure-regulated wound irrigation solution applicator, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5475 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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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
Category: Pressure-regulated wound irrigation solution applicator, manual
Irrisept Antimicrobial Wound Lavage by Irrimax Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pressure-regulated wound irrigation solution applicator, manual.
- Shur-Clens — Asept Pak, Inc. · Class II
- Shur-Clens — Asept Pak, Inc. · Class II
- Surgiphor — CAREFUSION 2200, INC. · Class II
- Shur-Clens — Asept Pak, Inc. · Class II
- Shur-Clens — Asept Pak, Inc. · Class II
- Vitale — CellEra, LLC · U
- Shur-Clens — Asept Pak, Inc. · Class II
- Shur-Clens — Asept Pak, Inc. · Class II
Cleared under the same submission
K210536 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Irrimax Corporation
Sources (1)
- FDA UDI 889cbb57-7b87-47d2-9106-25bfa6afa809 37 fields · synced May 30, 2026