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Device Explorer · FDA GUDID · GMDN 58824

Cardioplegia solution administration adaptor

A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basicall

US‑registered devices135in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile88%labelled sterile
Prescription59%Rx‑only share
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Share of device records

Medtronic, Inc.4533%
Med Michigan Holdings, Llc3627%
Livanova Usa, Inc.2519%
Novosci Corp.1713%
Vitalcor, Inc107%
Global Blood Resources Llc21%

Top labelers

CompanyDevicesShare
Medtronic, Inc.4533%
Med Michigan Holdings, Llc3627%
Livanova Usa, Inc.2519%
Novosci Corp.1713%
Vitalcor, Inc107%
Global Blood Resources Llc21%

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

Brand names on the register (sample)

Global Blood Resources TS3 Sentara Tubing SetGlobal Blood ResourcesCoronary Artery Perfusion CannulaSurge CardiovascularTerumo Cardiovascular SystemsPerfusion AdapterCardioplegia solution administration adaptorDLP™GOODWIN LUNG LINEGOODWIN HEART LINEEXTENSION LINE W/16 GA MODIFIED NEEDLEMETHODIST CARDIOPLEGIC ADMIN. SETCARDIOPLEGIA ADMINISTRATION SETLIFEGIFT CARDIOPLEGIC ADMIN SETLARGO MEDICAL LINE, MONITOR/ADMIN - 18 INLINE, M/A SPECIAL M-F - 18 IN

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

FDA product codes

CodeNameDevices
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass54
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypa50
DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPA42
DTRHeat-Exchanger, Cardiopulmonary Bypass6
FMGStopcock, I.V. Set2
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypa1

GMDN & GCC registration

  • GMDN code 58824 · non‑implantable
  • Single‑use 100% · sterile 88% · Rx‑only 59% · 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

Length (Centimeter) · 30Length (Meter) · 2Outer Diameter (Centimeter) · 1

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

How many cardioplegia solution administration adaptor products are registered in the US?

135 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardioplegia solution administration adaptor", from 6 companies. The largest labeler is Medtronic, Inc. with 33% of records.

Which FDA product codes apply?

DTL (Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass), DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypa), DWF (CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPA), DTR (Heat-Exchanger, Cardiopulmonary Bypass)

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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