Peritoneal Dialysis

6 catalogue numbers from 00884450277454, listed by Merit Medical Systems, Inc., United States, under System, Peritoneal, Automatic Delivery. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26
1manufacturer
6catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FKX
Manufacturer City Province Registered as Device types
Viant Medical Suzhou EPZ Co., Ltd. Jiangsu Jiangsu Contract manufacturer 3

Record

Regulatory record for Peritoneal Dialysis
Listed by Merit Medical Systems, Inc., United States
FDA product code FKX
Device type System, Peritoneal, Automatic Delivery
Device class Class 2
Regulation 21 CFR 876.5630
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published 2016-10-10
Record revised 2025-05-12 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 56

Catalogue Numbers

Catalogue numbers for Peritoneal Dialysis
Catalogue number Size Status
00884450277454 In distribution
00884450462782 In distribution
00884450277461 In distribution
00884450462751 In distribution
00884450277478 In distribution
00884450462775 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sharesource Connectivity Platform Baxter Healthcare Corporation 7
Liberty® Fresenius Medical Care 5
VersiPD Fresenius Medical Care 4
VersiPD Fresenius USA, Inc. 3
Liberty® PDx Fresenius Medical Care 3
Liberty Fresenius Medical Care Renal Therapies Group, LLC 2
Premier Fresenius Medical Care 2
Safe-Lock® Fresenius Medical Care 2
HomeChoice APD System Baxter Healthcare Corporation 2
LOW Recirculation Volume APD SET Baxter Healthcare Corporation 2
Sharesource Baxter Healthcare Corporation 2
HomeChoice PRO APD System Baxter Healthcare Corporation 2

Showing 12 of 38. All products under System, Peritoneal, Automatic Delivery

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer