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Device Explorer · FDA GUDID · GMDN 17605

Autotransfusion system blood component processing set

A collection of noninvasive devices that typically includes tubing, containers (e.g., bags or bowls for treatment, reinfusion, waste disposal) and filters intended to be used to process (filter/wash) blood components (e.g., red or white blood cells, platelets)

US‑registered devices163in commercial distribution
Companies6labelers on GUDID
Single‑use88%of device records
Sterile85%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Livanova Usa, Inc.4729%
Medtronic, Inc.3521%
Haemonetics Corporation3421%
Sorin Group Italia Srl2717%
Fresenius Kabi Ag1912%
Inquis Medical, Inc.11%

Top labelers

CompanyDevicesShare
Livanova Usa, Inc.4729%
Medtronic, Inc.3521%
Haemonetics Corporation3421%
Sorin Group Italia Srl2717%
Fresenius Kabi Ag1912%
Inquis Medical, Inc.11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ATV-F140C Vacuum Lines Combi-packAT3 Autotransfusion SetATF 120 Fast start kit with AT3ATF 40 Fast start kit with AT3ATR CAP SETATV-180 Vacuum LineATV-70 Vacuum LineATF 120 Fast Start KitATF 40 Fast Start KitATS Suction LineATO Oxygenator lineReinfusion bag 1000 mlReinfusion bag with Y-adapterATY Y-AdapterWaste bag 10 lATR 120 Autotransfusion Reservoir

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

FDA product codes

CodeNameDevices
CACAPPARATUS, AUTOTRANSFUSION111
CACApparatus, Autotransfusion54
CACApparatus, autotransfusion13
GKTSeparator, automated, blood cell, diagnostic9
DTNReservoir, blood, cardiopulmonary bypass9
DTNReservoir, Blood, Cardiopulmonary Bypass3

GMDN & GCC registration

  • GMDN code 17605 · non‑implantable
  • Single‑use 88% · sterile 85% · Rx‑only 97% · 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 (Milliliter) · 32Total Volume (Liter) · 20Pore Size (Micrometer) · 10

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

No closely related category with 50+ devices.

How many autotransfusion system blood component processing set products are registered in the US?

163 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Autotransfusion system blood component processing set", from 6 companies. The largest labeler is Livanova Usa, Inc. with 29% of records.

Which FDA product codes apply?

CAC (APPARATUS, AUTOTRANSFUSION), CAC (Apparatus, Autotransfusion), CAC (Apparatus, autotransfusion), GKT (Separator, automated, blood cell, diagnostic)

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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