Pressure Injectable Arrowg+ard Blue Plus(R) Three-Lumen CVC

EUDAMED

Class III (EU MDR)

Ref EU-42703-HPSK

by Arrow International LLC (Subsidiary of Teleflex Incorporated)

Identity

Trade Name: Pressure Injectable Arrowg+ard Blue Plus(R) Three-Lumen CVC EUDAMED
Device Name: AGB CVC Procedure Pack EUDAMED
Model / Reference: EU-42703-HPSK EUDAMED

Identifiers

Primary DI / UDI-DI: 10801902220520 EUDAMED
Basic UDI-DI: 08019020000000000000044KC EUDAMED
EMDN Code: C01020203 CENTRAL VENOUS MULTI-LUMEN (>2) 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

Pressure Injectable Arrowg+ard Blue Plus(R) Three-Lumen CVC by Arrow International LLC (Subsidiary of Teleflex Incorporated) — Class III — MDR — listed in…

Similar devices

Also classified as Central venous catheterization kit, short-term.

Acent-1 — Global Medikit Limited · Class III
Centurion — Centurion Medical Products · Class II
MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
Cook — COOK INCORPORATED · Class II
Shun Monitor® — Shunmei Medical Co.,Ltd · Class III
ARROW — TELEFLEX INCORPORATED · Class II
Medline Industries, Inc. — Centurion Medical Products · Class II
MEDLINE — MEDLINE INDUSTRIES, INC. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Arrow International LLC (Subsidiary of Teleflex Incorporated)
EUDAMED SRN: US-PR-000023158

Sources (1)

EUDAMED d19cfd58-cc9f-4676-bd0d-35f5f27c04e3 61 fields · synced Jul 13, 2026