ZOLL Circulation, Inc.

Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A

FDA Enforcement

Class I ·Ongoing·ZOLL Circulation, Inc.·April 23, 2025

Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050173

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

FDA Enforcement

Class II ·Terminated·Zoll Circulation, Inc.·January 16, 2013

Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.

FDA Enforcement

Class III ·Terminated·Zoll Circulation, Inc.·July 30, 2014

7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval.

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·December 3, 2014

AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR

FDA Enforcement

Class II ·Ongoing·ZOLL Circulation, Inc.·November 2, 2022

Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275

FDA Enforcement

Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021