Identity
- Trade Name
- Amecath X split catheter FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, implantable FDA UDI
- Device Name
- Permthane X split Long term dual lumen Pre-curved catheter kit size 12 Fr tip to cuff length 15.5 Cm total length 21 Cm FDA UDI
- Model / Reference
- PXDLC-1216-KPC FDA UDI
- Description
- Permthane X split Long term dual lumen Pre-curved catheter kit size 12 Fr tip to cuff length 15.5 Cm total length 21 Cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06221139059231 FDA UDI
- 510(k) Number
- K131814 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
- 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 12 French FDA UDILength — 16 Centimeter FDA UDI
Category: Double-lumen haemodialysis catheter, implantable
Amecath X split catheter by Ameco Medical Industries — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Double-lumen haemodialysis catheter, implantable.
- EvenMore — ANGIODYNAMICS, INC · Class II
- Palindrome — Mozarc Medical US LLC · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- HemoSplit Long-Term Hemodialysis Catheter — Bard Access Systems, Inc. · Class II
- Palindrome — Mozarc Medical US LLC · Class II
- HEMO-FLOW® — MEDICAL COMPONENTS INC · Class II
- DuraFlow™2 — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K131814 also covers:
- Amecath Twincath catheter — Ameco Medical Industries
- Amecath Twincath catheter — Ameco Medical Industries
- Amecath Twincath catheter — Ameco Medical Industries
- Amecath Twincath catheter — Ameco Medical Industries
- Amecath Twincath catheter — Ameco Medical Industries
- Amecath Twincath catheter — Ameco Medical Industries
- Amecath Twincath catheter — Ameco Medical Industries
- Amecath Twincath catheter — Ameco Medical Industries
- Amecath Twincath catheter — Ameco Medical Industries
- Amecath Twincath catheter — Ameco Medical Industries
- Amecath Twincath catheter — Ameco Medical Industries
- Amecath Twincath catheter — Ameco Medical Industries
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
- Ameco Medical Industries
Sources (1)
- FDA UDI 78042997-7df1-4d79-be4b-e4d02cb65c1d 36 fields · synced May 31, 2026