Question 1

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

Accepted Answer

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.

Question 2

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

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Peritoneal Dialysis Drainage Set No. 48-0025-6	K895991	FDA 510(k)	Class II	Active
Dextrolyte Ii, Single Use Y Set No. 48-6360-1	K896600	FDA 510(k)	Class II	Active
Hollow Fiber Dialyzer Focus 70h	K893677	FDA 510(k)	Class II	Active
Long-Life Y-Set Cat. No. 48-6366-8	K902451	FDA 510(k)	Class II	Active
Dextrolyte Ii, Peritoneal Dialysis Cycler Set -(8)	K896599	FDA 510(k)	Class II	Active
Modified Labeling To Model 9608 Arterial Hemo Bld.	K895244	FDA 510(k)	Class II	Active
Peritoneal Dialysis Cycler Set, W/8 Prong Manifold	K892871	FDA 510(k)	Class II	Active
Universal Connector Catalog No. 48-1025-5	K896764	FDA 510(k)	Class II	Active
J-Tip Injector	K973254	FDA 510(k)	Class II	Active
Dextrolyte Ii Peritoneal Dialysis 48-3029-7 Clamp	K920697	FDA 510(k)	Class II	Active
Advanced Perform Hollow Fiber Dialyzer, 019752-5	K861537	FDA 510(k)	Class II	Active
Peritoneal Dialysis Cycler Set	K900323	FDA 510(k)	Class II	Active
Peritoneal Dialysis Cycler Set, W/5 Prong Manifold	K892870	FDA 510(k)	Class II	Active
Multiple Artificial Kidney Systems (maks) #idm	K874084	FDA 510(k)	Class II	Active
Accuflo Uf Control Module No. 74-0100-3	K883490	FDA 510(k)	Class II	Active

National Medical Care, Medical Products Div., Inc.

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

Frequently asked questions

Information

Catalogue (65)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities