Identity
- Trade Name
- Two-Lumen Hemodialysis Catheter for High Volume Infusions EUDAMEDARROW FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, nonimplantable FDA UDI
- Device Name
- AHDC Procedure Pack EUDAMEDTwo-Lumen Hemodialysis Catheter for High Volume Infusions FDA UDI
- Model / Reference
- CS-12122-E EUDAMEDIPN919710 FDA UDI
- Description
- Two-Lumen Hemodialysis Catheter for High Volume Infusions FDA UDI
Identifiers
- Catalog Number
- CS-12122-E FDA UDI
- Primary DI / UDI-DI
- 10801902190229 EUDAMEDFDA UDI
- Basic UDI-DI
- 08019020000000000000046KG EUDAMED
- FDA Product Code
- LFJ FDA UDI
- EMDN Code
- C01020202 CENTRAL VENOUS DOUBLE-LUMEN CATHETERS, NON-TUNNELED EUDAMED
- GMDN Term
- Double-lumen haemodialysis catheter, nonimplantable FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5540 FDA UDI
- Medical Purpose
- The large-bore two-lumen catheter permits venous access to the central circulation for temporary or short-term hemodialysis and apheresis. It may be inserted in the jugular subclavian or femoral veins. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA 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
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
Yes
FDA UDI
Category: Double-lumen haemodialysis catheter, nonimplantable
Arrow by Teleflex Incorporated — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (2)
- FDA UDI b3e8f0cf-1e22-4cc4-998e-a9b7c2d4d107 35 fields · synced Oct 5, 2026
- EUDAMED 951845a3-f56f-42a2-85ee-6b5b43b0c0bc 61 fields · synced Oct 5, 2026