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Arrowg+ard Blue(R) Two-Lumen CVC
EUDAMEDClass III (EU MDR)
Ref CV-25802-E
by Arrow International LLC (Subsidiary of Teleflex Incorporated)
Identity
- Trade Name
- Arrowg+ard Blue(R) Two-Lumen CVC EUDAMED
- Device Name
- AGB CVC Procedure Pack EUDAMED
- Model / Reference
- CV-25802-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10801902212570 EUDAMED
- Basic UDI-DI
- 08019020000000000000044KC EUDAMED
- EMDN Code
- C01020202 CENTRAL VENOUS DOUBLE-LUMEN CATHETERS, NON-TUNNELED EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The Arrow catheter is indicated to permit short-term (< 30 day) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following: • Lack of usable peripheral IV sites • Central venous pressure monitoring • Total parenteral nutrition (TPN) • Infusions of fluids, medications, or chemotherapy • Frequent blood sampling or receiving blood transfusions/blood products • Injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable CVC may not exceed 400 psi. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Central venous catheterization kit, short-term
Arrowg+ard Blue(R) Two-Lumen CVC by Arrow International LLC (Subsidiary of Teleflex Incorporated) — Class III — MDR — listed in EUDAMED
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Also classified as Central venous catheterization kit, short-term.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08019020000000000000044KC | Class III | Active |
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Manufacturer
- EUDAMED SRN
- US-PR-000023158
Sources (1)
- EUDAMED 28fc9dd4-0852-4174-948d-0f213e28597c 61 fields · synced Jun 18, 2026