Identity
- Trade Name
- OneCath Hydro FDA UDI
- Generic Name
- Single-administration urethral catheterization kit, single-use FDA UDI
- Device Name
- The OneCath-Hydro Hydrophilic Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems. FDA UDI
- Model / Reference
- 2031-0812 FDA UDI
- Description
- The OneCath-Hydro Hydrophilic Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems. FDA UDI
Identifiers
- Catalog Number
- 2031-0812 FDA UDI
- Primary DI / UDI-DI
- 10810053920043 FDA UDI
- FDA Product Code
- GBM FDA UDI
- GMDN Term
- Single-administration urethral catheterization kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 8 Inch FDA UDICatheter Gauge — 12 French FDA UDI
Category: Single-administration urethral catheterization kit, single-use
OneCath Hydro by Compactcath, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- LoFric® Origo™ — Wellspect AB · Class II
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
- Compactcath, Inc
Sources (1)
- FDA UDI 81b03407-ac07-4891-acbb-95f1e1b64c13 36 fields · synced Jun 1, 2026