Consulting Wallah › Device Explorer › Dialysis & renal › Peritoneal dialysis system tubing set
Device Explorer · FDA GUDID · GMDN 35000

Peritoneal dialysis system tubing set

A sterile set intended for the administration of peritoneal dialysis. It will typically consist of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysis filter to trap and remove contaminating particles. This is a

US‑registered devices78in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile88%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Fresenius Medical Care Holdings, Inc.2127%
Vantive Us Healthcare Llc1722%
Baxter International Inc.1621%
Baxter Healthcare Corporation912%
Utah Medical Products, Inc.79%
Simergent, Llc34%
Fresenius Medical Care Renal Therapies Group, Llc23%
Byonyks Private Limited23%

Top labelers

CompanyDevicesShare
Fresenius Medical Care Holdings, Inc.2127%
Vantive Us Healthcare Llc1722%
Baxter International Inc.1621%
Baxter Healthcare Corporation912%
Utah Medical Products, Inc.79%
Simergent, Llc34%
Fresenius Medical Care Renal Therapies Group, Llc23%
Byonyks Private Limited23%
Baxter Healthcare Sa11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MINICAP EXTENDED LIFE PD TRANSFER SET WITH TWISTLOW RECIRCULATION VOLUME APD SETHOMECHOICE APD SETMANIFOLD SETLow Recirculation Volume APD Set with Cassette (Locking Cap for Peritoneal Dialysis Catheter AdaAPD DRAIN MANIFOLDEmpty Sterile ContainerAUTOMATED PD SETINTERGRATED APD SETMinicapExtension Set with EASY-LOCK ConnectorMiniCap Extended Life PD Transfer Set with TwistFLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLEffluent Sample BagCYCLER DRAINAGE BAG

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KDJSET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE30
FKXSYSTEM, PERITONEAL, AUTOMATIC DELIVERY18
FKXSystem, peritoneal, automatic delivery10
FKXSystem, Peritoneal, Automatic Delivery8
FKOCatheter, Peritoneal Dialysis, Single Use7
KDJSet, Administration, For Peritoneal Dialysis, Disposable5

GMDN & GCC registration

  • GMDN code 35000 · non‑implantable
  • Single‑use 100% · sterile 88% · Rx‑only 99% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Liter) · 5Length (Feet) · 4Length (Inch) · 1

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many peritoneal dialysis system tubing set products are registered in the US?

78 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Peritoneal dialysis system tubing set", from 9 companies. The largest labeler is Fresenius Medical Care Holdings, Inc. with 27% of records.

Which FDA product codes apply?

KDJ (SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE), FKX (SYSTEM, PERITONEAL, AUTOMATIC DELIVERY), FKX (System, peritoneal, automatic delivery), FKX (System, Peritoneal, Automatic Delivery)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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