Identity
- Trade Name
- HEMO-CATH® FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, implantable FDA UDI
- Device Name
- 12.5F X 28CM PRE-CURVED12.5F X 2 HEMO-CATH®LT SILICONE DOUBLE LUMEN CATHETERDOUBLE LUME (CUFF 23CM FROM TIP)(CUFF 23CM F FDA UDI
- Model / Reference
- DSL28CPC FDA UDI
- Description
- 12.5F X 28CM PRE-CURVED12.5F X 2 HEMO-CATH®LT SILICONE DOUBLE LUMEN CATHETERDOUBLE LUME (CUFF 23CM FROM TIP)(CUFF 23CM F FDA UDI
Identifiers
- Catalog Number
- DSL28CPC FDA UDI
- Primary DI / UDI-DI
- 00884908144901 FDA UDI
- FDA Product Code
- MSD FDA UDI
- GMDN Term
- Double-lumen haemodialysis catheter, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5540 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Hemo-Cath® by Medical Components Inc — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Components Inc
Sources (1)
- FDA UDI 6473aee8-20e1-4124-a2a5-0bfc35e45185 36 fields · synced May 30, 2026