Identity
- Trade Name
- SUR-FIT NATURA FDA UDI
- Generic Name
- Colostomy irrigation kit, single-use FDA UDI
- Device Name
- Visi-Flow® Irrigation Sleeve Transparent 2 3/4" FDA UDI
- Model / Reference
- 401914 FDA UDI
- Description
- Visi-Flow® Irrigation Sleeve Transparent 2 3/4" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00768455104024 FDA UDI
- FDA Product Code
- EXD FDA UDI
- GMDN Term
- Colostomy irrigation kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5895 FDA UDI
- Commercial Distribution
- 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
No
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
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
- Length — 7 Centimeter FDA UDI
Category: Colostomy irrigation kit, single-use
Sur-Fit Natura by Convatec, Purchasing Department — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SUR-FIT NATURA — CONVATEC, PURCHASING DEPARTMENT · Class II
- SUR-FIT NATURA — CONVATEC, PURCHASING DEPARTMENT · Class II
- NATURA — CONVATEC, PURCHASING DEPARTMENT · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Convatec, Purchasing Department
Sources (1)
- FDA UDI e8306e06-9f02-4d16-abe0-adc32996dac5 35 fields · synced Jun 1, 2026