Identity
- Trade Name
- SimPro™ Set FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- Single Use Urinary Catheter with water sachet and Accessories. Fem/Ped Nelaton 8" 08FR FDA UDI
- Model / Reference
- 5330800 FDA UDI
- Description
- Single Use Urinary Catheter with water sachet and Accessories. Fem/Ped Nelaton 8" 08FR FDA UDI
Identifiers
- Catalog Number
- 5330800 FDA UDI
- Primary DI / UDI-DI
- 07333387043494 FDA UDI
- FDA Product Code
- FAQ FDA UDIEZD FDA UDINWO FDA UDIEYY FDA UDILYZ FDA UDI
- GMDN Term
- Single-administration urethral catheterization kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5250 FDA UDI876.5130 FDA UDI878.4370 FDA UDI880.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Catheter Gauge — 8 French FDA UDILength — 8 Inch FDA UDI
Category: Single-administration urethral catheterization kit, single-use
The SimPro Set is a single-use, sterile urinary catheter with a water sachet and accessories. It is designed for one-time use in the urology department, making it an ideal solution for patients who require a temporary urinary catheterization. The device features a 8 French gauge catheter, a 8 inch length, and a dry storage condition that requires a special place in a room at a temperature below 70 degrees.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Wellspect AB
Sources (1)
- FDA UDI 8918f11f-22ae-43eb-b6d1-a410fdde17cd 37 fields · synced Jun 22, 2026