Cardinal Health Costa Rica, S.A.

FDA Device Registration & Listing · -- Alajuela, CR · Registration 3009211636

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009211636
FEI Number
3009211636
Entity Name
Cardinal Health Costa Rica, S.A.
City/State/Country
-- Alajuela, CR
Establishment Address
Edificio B20 Calle #2 Zona Franca Coyol, -- Alajuela --, CR
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Cardinal Health 200, LLC (Owner Number: 9028292)
Owner / Operator Contact Address
3651 Birchwood Drive, --, Waukegan, IL 60085, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2007-12-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2018-07-27
LZH Pump, Infusion, Enteral General Hospital Class 2 880.5725 2023-01-24
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2008-01-10
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2022-03-21
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2022-03-21
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2018-07-27
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2018-07-27
FKO Catheter, Peritoneal Dialysis, Single Use Gastroenterology, Urology Class 2 876.5630 2018-08-02
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2018-08-02
FRN Pump, Infusion General Hospital Class 2 880.5725 2018-07-27
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2018-07-27
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2007-12-18
FKO Catheter, Peritoneal Dialysis, Single Use Gastroenterology, Urology Class 2 876.5630 2018-07-27
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2018-07-27
NFK Kit, Repair, Catheter, Hemodialysis Gastroenterology, Urology Class 2 876.5540 2018-07-27
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2018-07-27
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2019-06-17
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2018-07-27
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2022-03-21
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-01-17
NYU Catheter, Hemodialysis, Implanted, Coated Gastroenterology, Urology Class 2 876.5540 2018-07-27
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2018-07-27
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2018-07-27
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2014-05-05
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2014-05-05
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 1999-08-04
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2018-07-27
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2021-08-17
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2018-07-27
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2018-07-27
LZH Pump, Infusion, Enteral General Hospital Class 2 880.5725 2018-07-27
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2014-07-07
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2018-07-27
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2016-06-08
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2021-08-17
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2014-05-05
NFK Kit, Repair, Catheter, Hemodialysis Gastroenterology, Urology Class 2 876.5540 2018-07-27
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2021-08-17
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-07-27
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2023-08-17
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2018-07-27
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2018-07-27
OWL Peripheral Catheter Insertion Kit General Hospital Class 2 880.5200 2011-11-11
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2018-07-27
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2010-10-18
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2018-07-27
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-01-16
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2008-01-16
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2007-12-18
LZH Pump, Infusion, Enteral General Hospital Class 2 880.5725 2023-01-18
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) General Hospital Class 2 880.5780 2014-09-16
FOS Catheter, Umbilical Artery General Hospital Class 2 880.5200 2008-01-16
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2018-07-27
DRB Stylet, Catheter Cardiovascular Class 2 870.1380 2022-03-21
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-04-12
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2018-07-27

Official Correspondent

No official correspondent registered.

US Agent Details

Stacey Henning Email: stacey.henning@cardinalhealth.com Phone: (312) 2702081

Related Public Records

Same Entity

Cardinal Health 200, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004839227 Cardinal Health Malta 212 Ltd Marsa, MT
3015541720 Cardinal Health Germany Manufacturing GmbH Halberstadt Saxony-Anhalt, DE
1033903 Cardinal Health Greenwood, SC, US
9611018 Cardinal Health Ireland Manufacturing Limited TULLAMORE Offaly, IE
8040459 Kendall-Gammatron Limited SAMPRAN Nakhon Pathom, TH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K170216 Tactile Systems Technology, Inc. (Dba Tactile Medical) Flexitouch System 2017-05-26
K100306 Covidien KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES 2010-05-04
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26
K122854 Arrow International (Subsidiary of Teleflex Inc.) ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER 2013-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0001-2011 Baxter Healthcare Corp. Rt. 2
Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011 Baxter Healthcare Corp. Rt. 2
Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025 Zyno Medical LLC 2
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z

Similar Registrations

Registration Number Establishment Name Location
3033981998 KOYA MEDICAL, INC. Dallas, TX, US
3020703724 Therma Bright Inc. Toronto Ontario, CA
3014491159 AIROS MEDICAL INC Audubon, PA, US
3014834638 ZENITH TECHNICAL INNOVATIONS, LLC Gurnee, IL, US
3009155917 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Shenzhen Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009211636. Last updated year: 2026. Please use registration number 3009211636 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.