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Silicone Hemo-Cath-No Cuff/Acutesilicone Hemo-Cath-No Cuff/Acute
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SILICONE HEMO-CATH-NO CUFF/ACUTESILICONE HEMO-CATH-NO CUFF/ACUTE FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, implantable FDA UDI
- Device Name
- 11.5F X 24CM HEMO-CATH® SILICONE DOUBLE LUMENSILICONE DO CATHETER SET W/STYLETCATHETER SE FDA UDI
- Model / Reference
- DSL24 FDA UDI
- Description
- 11.5F X 24CM HEMO-CATH® SILICONE DOUBLE LUMENSILICONE DO CATHETER SET W/STYLETCATHETER SE FDA UDI
Identifiers
- Catalog Number
- DSL24 FDA UDI
- Primary DI / UDI-DI
- 00884908141832 FDA UDI
- FDA Product Code
- LFJ 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
- 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
Category: Double-lumen haemodialysis catheter, implantable
Silicone Hemo-Cath-No Cuff/Acutesilicone Hemo-Cath-No Cuff/Acute by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Double-lumen haemodialysis catheter, implantable.
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- Palindrome — Mozarc Medical US LLC · Class II
- DuraFlow™2 — Merit Medical Systems, Inc. · 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
- Medical Components Inc
Sources (1)
- FDA UDI e4a705cb-c369-4636-8bcc-5ef526f135ec 35 fields · synced Jun 8, 2026