Identity
- Trade Name
- Twin-Cath(R) 18/20 Two-Lumen Peripheral Catheter EUDAMEDARROW FDA UDI
- Generic Name
- Peripherally-inserted central venous catheter FDA UDI
- Device Name
- TwinCath Catheter Procedure Pack EUDAMEDTwin-Cath(R) 18/20 Two-Lumen Peripheral Catheter FDA UDI
- Model / Reference
- IV-01100 EUDAMEDIPN925064 FDA UDI
- Description
- Twin-Cath(R) 18/20 Two-Lumen Peripheral Catheter FDA UDI
Identifiers
- Catalog Number
- IV-01100 FDA UDI
- Primary DI / UDI-DI
- 10801902210477 EUDAMEDFDA UDI
- Basic UDI-DI
- 08019020000000000000238KT EUDAMED
- 510(k) Number
- K862153 FDA UDI
- FDA Product Code
- FOZ FDA UDI
- EMDN Code
- C01010103 PERIPHERAL I.V. CATHETERS, WITH INTEGRATED EXTENSIONS EUDAMED
- GMDN Term
- Peripherally-inserted central venous catheter FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Medical Purpose
- Twin-Cath is intended to provide short-term (< 30 days) peripheral venous access. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA 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
Category: Peripherally-inserted central venous catheter
Arrow by Teleflex Incorporated — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripherally-inserted central venous catheter.
- BioFlo — NAVILYST MEDICAL, INC. · Class II
- Synergy — Health Line International Corp · Class II
- PowerPICC — Bard Access Systems, Inc. · Class II
- PowerPICC Provena — Bard Access Systems, Inc. · Class II
- BioFlo — NAVILYST MEDICAL, INC. · Class II
- Synergy — Health Line International Corp · Class II
- BioFlo — NAVILYST MEDICAL, INC. · Class II
- Midline Catheter — MEDICAL COMPONENTS INC · Class II
Cleared under the same submission
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 4f54e409-e554-4c9c-ad7f-fa4f8da48cb3 36 fields · synced Aug 2, 2026
- EUDAMED 2f1e8b23-4141-449b-ba6a-b89669e8b1d4 61 fields · synced Aug 2, 2026