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National Medical Care, Medical Products Div., Inc.

US

Last updated May 23, 2026

What National Medical Care, Medical Products Div., Inc. makes

National Medical Care’s Medical Products Division manufactures peritoneal dialysis components, including cycler sets, transfer sets, bloodlines, venous lines, and dissolution modules for continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD). Their products also include specialized connectors like rapid-disconnect Y-sets and manifolds designed for fluid transfer in dialysis procedures.

The company’s devices are classified as Class II under the FDA’s regulatory framework and are listed via the 510(k) clearance process. These products are intended for use in the United States, where the manufacturer is based.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does National Medical Care’s Medical Products Division manufacture?

National Medical Care’s Medical Products Division specializes in peritoneal dialysis components. These include cycler sets for automated peritoneal dialysis (APD), transfer sets for continuous ambulatory peritoneal dialysis (CAPD), arterial and venous bloodlines, venous lines, dissolution modules, and specialized connectors like rapid-disconnect Y-sets and manifolds. These products are designed to facilitate fluid transfer and dialysis procedures.

Where is National Medical Care’s Medical Products Division based, and where are their devices intended for use?

National Medical Care’s Medical Products Division is based in the United States. Their devices are specifically intended for use within the U.S. regulatory environment, where they undergo evaluation and clearance processes.

Which regulatory registries or databases list National Medical Care’s devices?

National Medical Care’s devices are listed in the FDA’s 510(k) registry. This registry includes Class II medical devices that have undergone the 510(k) clearance process, demonstrating compliance with FDA requirements for safety and effectiveness.

How are National Medical Care’s devices classified under FDA regulations?

National Medical Care’s devices are classified as Class II under the FDA’s regulatory framework. Class II devices require special controls in addition to general controls to ensure their safety and performance, and they must go through the 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
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Catalogue (65)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
J-Tip 8164200125
FDA UDI
Class IIActive
Dextrolyte Ii Capd Transfer Set - No. 48-4009-6 K895792
FDA 510(k)
Class IIActive
Arterial/Venous Bloodlines K901688
FDA 510(k)
Class IIActive
Dextrolyte Ii, Peritoneal Dialysis Cycler Set K900008
FDA 510(k)
Class IIActive
Dextrolyte Ii, Peritoneal Dialysis Cycler Set W/3 K900140
FDA 510(k)
Class IIActive
Peritoneal Dialysis Cycler Set K914363
FDA 510(k)
Class IIActive
National Medical Care Venous Line 03-9548 K894637
FDA 510(k)
Class IIActive
Dextrolyte Ii Peritoneal Dialysis Cycler Set K895990
FDA 510(k)
Class IIActive
Label Chg For Erika Model 9608 Arterial Blood Line K870722
FDA 510(k)
Class IIActive
Dextrolyte Ii, W/5 Prong Manifold No. 48-1003-2 K900142
FDA 510(k)
Class IIActive
Two Tank Dissolution Module K893612
FDA 510(k)
Class IIActive
Dextrolyte Ii Peritoneal Dialysis 48-3028-9 K920693
FDA 510(k)
Class IIActive
Rapid Disconnect Y-Set, Cat. No. 48-7000 K930843
FDA 510(k)
Class IIActive
Dextrolyte Ii, Manual Administration Set 48-1032-1 K900005
FDA 510(k)
Class IIActive
Dextrolyte Ii Capd Trnsfer Set K920029
FDA 510(k)
Class IIActive
Negative Pressure Arterial Line Cat. No: 03-9630 K903021
FDA 510(k)
Class IIActive
Naturalyte Mixer K883408
FDA 510(k)
Class IIActive
Dextrolyte Ii, Peritoneal Dialysis No. 48-1015-6 K900243
FDA 510(k)
Class IIActive
Hollow Fiber Dialyzer, Bio Care Ps 130 K900018
FDA 510(k)
Class IIActive
Catheter Adapter Co-Pak Catalog No. 48-0122-1 K896763
FDA 510(k)
Class IIActive
Dextrolyte Ii, Peritoneal Dialysis Cycler Set K900012
FDA 510(k)
Class IIActive
Modification's To Toray's B-2 Series K863297
FDA 510(k)
Class IIActive
Focua 90r, 90hr, 120r, 120hr, 160r, 160hr Hollow Fiber Dialyzer K952343
FDA 510(k)
Class IIActive
Erika Arterial Line 03-9837-0 K853962
FDA 510(k)
Class IIActive
Hollow Fiber Dialyzer Focus 9or/90h-R/120r/120h-R K914790
FDA 510(k)
Class IIActive
Advanced Perform Hollow Fiber Dialyzer, 01-9751-7 K861536
FDA 510(k)
Class IIActive
Dextrolyte Ii Peritoneal Dialysis Admin. Set K920586
FDA 510(k)
Class IIActive
Hollow Fiber Dialyzer Focus 70, 90, 120, 90h, 120h K871236
FDA 510(k)
Class IIActive
Dextrolyte Ii, Peritoneal Dialysis No. 48-1031-3 K900242
FDA 510(k)
Class IIActive
Dextrolyte Ii, Peritoneal Dialysis No. 48-1001-6 K900226
FDA 510(k)
Class IIActive
Toray Filtryzer Dialyzer, B1-2.0. K862693
FDA 510(k)
Class IIActive
Dextrolyte Ii, W/5 Prong Manifold No. 48-1100-6 K900141
FDA 510(k)
Class IIActive
Catheter Extension Set Cat. No. 48-3027-9 K895992
FDA 510(k)
Class IIActive
Hemodialysis Blood Tubing Set K920797
FDA 510(k)
Class IIActive
Advanced Performance Hollow Fiber Dialyzer K861916
FDA 510(k)
Class IIActive
Formalin Reuse Cart K941757
FDA 510(k)
Class IIActive
Erika Arterial Line 03-9625-9 K860740
FDA 510(k)
Class IIActive
Nmc Cycler Machine K905809
FDA 510(k)
Class IIActive
Peritoneal Dialysis Cycler Set W/12 Prong Manifold K892872
FDA 510(k)
Class IIActive
Four Tank Dissolution Module K864635
FDA 510(k)
Class IIActive
Hollow Fiber Dialyzer Series Focus 160/160h K895759
FDA 510(k)
Class IIActive
Convertible Adapter Catalog No. 48-4039-3 K900004
FDA 510(k)
Class IIActive
Dextrolyte Ii Peritoneal Dialysis Pump K915628
FDA 510(k)
Class IIActive
Catheter Adapter Sealing Cap No. 48-1028-9 K900006
FDA 510(k)
Class IIActive
Capillary Flow Hollow Fiber Dialyzers K863044
FDA 510(k)
Class IIActive
Combilines Hemodialysis Blood Tubing Set K962081
FDA 510(k)
Class IIActive
Transfer Set Sealing Cap, Cat. No. 48-1027-1 K896761
FDA 510(k)
Class IIActive
Quick Disconnect Clamp Catalog No. 48-0300-3 K896956
FDA 510(k)
Class IIActive
J-Tip Needless Injector K980082
FDA 510(k)
Class IIActive
Maks Central Delivery Systems Models 11-425/11-445 K861472
FDA 510(k)
Class IIActive

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