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Device Explorer · FDA GUDID · GMDN 47572

Apheresis system tubing set

A collection of sterile, flexible, plastic tube segments and associated items (e.g., connectors, line clamp, drip chamber) intended to be used in an apheresis system to channel blood from the patient to an appropriate apheresis column before being returned to

US‑registered devices67in commercial distribution
Companies8labelers on GUDID
Single‑use91%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Haemonetics Corporation2537%
Fresenius Kabi Ag2436%
Terumo Bct, Inc.710%
Jms Singapore Pte Ltd46%
Fenwal, Inc.34%
Asahi Kasei Medical America Inc.23%
Kaneka Pharma America Llc11%
Nxstage Medical, Inc.11%

Top labelers

CompanyDevicesShare
Haemonetics Corporation2537%
Fresenius Kabi Ag2436%
Terumo Bct, Inc.710%
Jms Singapore Pte Ltd46%
Fenwal, Inc.34%
Asahi Kasei Medical America Inc.23%
Kaneka Pharma America Llc11%
Nxstage Medical, Inc.11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Accessory Plasma Storage SetsAccessory Waste BagAccessory Platelet Bag with Integrated SamplerAccessory Platelet Storage SetsSpectra Optia®Anticoagulant Connection AdapterTPE Plasma Exchange SetFenwal PLASMACELL-C Disposable SetFenwal PLASMACELL-C Disposable Set For Use With Fenwal AMICUS Apheresis Kit-Double Needle w/PlatFenwal AMICUS Apheresis Kit- SingleNeedle w/PlatPLASMACELL Xi Disposable Set with SPIKESMARTALYX 2RBC-LR Kit with Saline SpikeALYX Plasma KitALYX RBC/PLASMA KITAMICUS Apheresis Kit – Double Needle with Platel

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

FDA product codes

CodeNameDevices
GKTSeparator, Automated, Blood Cell, Diagnostic36
GKTSeparator, automated, blood cell, diagnostic25
FIENeedle, Fistula12
LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic4
KSRCONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLO4
FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 D4

GMDN & GCC registration

  • GMDN code 47572 · non‑implantable
  • Single‑use 91% · sterile 100% · Rx‑only 99% · OTC 1%
  • 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 (Milliliter) · 23Needle Gauge (Gauge) · 12Length (Inch) · 8

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

No closely related category with 50+ devices.

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

67 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Apheresis system tubing set", from 8 companies. The largest labeler is Haemonetics Corporation with 37% of records.

Which FDA product codes apply?

GKT (Separator, Automated, Blood Cell, Diagnostic), GKT (Separator, automated, blood cell, diagnostic), FIE (Needle, Fistula), LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic)

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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