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Address: 3000 Kent Ave, West Lafayette, Indiana 47906, USA
www.vasc-alert.com |
Send Inquiry |
Phone: +1-(765)-775-2525
FDA Registration: 3003574195 Year Established: 2002
Annual Revenues: USD 1-5 Million
Products: Remote Accessories Hemodialysis System (FDA Code:
MON), ...
Vasc-Alert provides proactive surveillance of hemodialysis patients' access sites by evaluating the intra-access pressures. The program analyzes the hemodialysis machine blood flow and pressure data t
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Address: 1112 Chatburn Ave., Harlan, Iowa 51537, USA
www.moldedproducts.com |
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Phone: +1-(712)-755-5557, 800-435-8957
FDA Registration: 1932668 Year Established: 1986
Quality: ISO 9001, ISO 13485 Certified
Products: Caps, Wound Care, Transducer Protectors, Disposable Surgical Forceps, General & Plastic Surgery Forceps (FDA Code:
GEN), Syringe Adapter, ...
Molded Products specializes in product categories such as sink systems, specialized dialysis, wound care and specialty connectors. Our product list comprises of syringe adapters, fistula pressure clam
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Address: 439 South Union St., 5th Floor, Lawrence, Massachusetts 01843, USA
www.nxstage.com |
Phone: +1-(978)-687-4700, 866-697-8243
FDA Registration: 3009141079
Products: Laboratory Grade Water Purification Systems, Millipore Water Purification Systems, Analytical-Grade Water Purification Systems, Solar Powered Water Purification Systems, Lab Water Purification Systems, Water Purification Subsystem (FDA Code:
FIP), ...
Nxstage Medical, Inc. specializes in bloodlines, needles and products for in-center dialysis and pheresis applications. Our NxStage System One™ helps make daily and home therapy more accessible.
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Address: Eimattstrasse 3, Oberdorf CH-4436, Switzerland
www.synthes.com |
Send Inquiry |
Phone: +41-(61)-9656666
FDA Registration: 8030965
Products: Small Depth Gauge (FDA Code:
HTJ), Depth Gauge (FDA Code:
HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code:
HTJ), ...
Synthes GmbH develops, produces and markets instruments, implants & biomaterials for the surgical fixation, correction & regeneration of the skeleton & its soft tissues. Trauma implants and instrument
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Address: Ikarusallee 15, Hannover D30179, Germany
www.ibpmedical.com |
Phone: +49-(511)-651647
FDA Registration: 3003884198
Products: Dialysis Standard-Conductivity Solution-Test (FDA Code:
FKH), Non-Remote Conductivity Meter (FDA Code:
FIZ), Remote Accessories Hemodialysis System (FDA Code:
MON), ...
IBP Medical Gmbh provides reference meters, calibration services and heat exchangers for dialysis machines. The IBPView software allows for graphic display of the measuring results on any PC and allow
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FDA Code / Regulation: MON / 876.5820 A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.