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BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.

FDA Enforcement
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FDA Enforcement
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Fixone Biocomposite Anchor

FDA Enforcement
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Genesis Knotless Anchor

FDA Enforcement
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Genesis Dual Thread Screw-In Anchor

FDA Enforcement
Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

Genesis Screw-In Anchor

FDA Enforcement
Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

AlternatiV+ Max Knotless Anchor

FDA Enforcement
Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

AlternatiV+ Screw-In Anchor

FDA Enforcement
Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

Fixone Hybrid Anchor

FDA Enforcement
Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026