Consulting Wallah › Device Explorer › Procedure kits & trays › Cardiothoracic surgical procedure kit, non-medicat
Device Explorer · FDA GUDID · GMDN 61371

Cardiothoracic surgical procedure kit, non-medicated, single-use

A collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothorac

US‑registered devices24,177in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Cardinal Health 200, Llc24,05699%
Aligned Medical Solutions1010%
Thoratec Corporation130%
Packroom Llc30%
Dermapac Inc.30%
Integrated Medcraft Llc10%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc24,05699%
Aligned Medical Solutions1010%
Thoratec Corporation130%
Packroom Llc30%
Dermapac Inc.30%
Integrated Medcraft Llc10%

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

Brand names on the register (sample)

HeartMate 3™HeartMate™Thoratec® HeartMate 3™CARDINAL HEALTHEMS Chest Tube Insertion Kit, 24FrNEGA Open Heart *RFID PBNEGA Thoracic CVOR *RFID PBHuntsville Open Heart*PBThoratec® HeartMate 3™ Surgical Accessories SparThorate® VAD, Surgical Implant Accessory KitTHORATEC® HEARTMATE II®, THREAD PROTECTOR SETTHORATEC® HEARTMATE II®, SKIN CORING PUNCHTHORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAligned Medical SolutionsDermapac, Inc.

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

FDA product codes

CodeNameDevices
OEZCardiovascular procedure kit21,863
OEQAngiography/angioplasty kit1,052
OESCardiac catheterization kit956
OEZCardiovascular Procedure Kit287
OFGCT biopsy tray71
OFECentral venous blood pressure kit63

GMDN & GCC registration

  • GMDN code 61371 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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

No structured size data on the register.

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

How many cardiothoracic surgical procedure kit, non-medicated, single-use products are registered in the US?

24,177 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiothoracic surgical procedure kit, non-medicated, single-use", from 6 companies. The largest labeler is Cardinal Health 200, Llc with 99% of records.

Which FDA product codes apply?

OEZ (Cardiovascular procedure kit), OEQ (Angiography/angioplasty kit), OES (Cardiac catheterization kit), OEZ (Cardiovascular Procedure Kit)

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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