Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005458990

FEI Number

3005458990

Entity Name

CAIR TUNISIE

City/State/Country

Kalaa Kebira Sousse, TN

Establishment Address

Lot. No. 46 Zone Industrielle Kala Kebira, Kalaa Kebira Sousse 4060, TN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Cair LGL (Owner Number: 10055478)

Owner / Operator Contact Address

Parc Tertiaire De Bois Dieu, 1 Allee Des Chevreuils, Lissieu, FR-69 69930, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171117

PMA Number

N/A

All Registered Proprietary Names

CareFusion Neutraclear multi-fuse Extension Set with needle-free connector(s) Guerbet 150cm Straight Extension/Injection Line for CT & MRI Vesco Pediatric Enteral Feeding Tube with ENFit in PU Vesco Enteral Feeding Tube with ENFit in PVC Carefusion NeutraClear Needle-free connector Nutricair Enteral-Enfit Carefusion NeutraClear Needle-Free Connector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-09-06
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2022-09-09
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2022-09-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-09-09
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2023-02-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-09-06

Official Correspondent

Alexandre Lopez

US Agent Details

Irving Wiesen Business: Law Offices of Irving L. Wiesen P.C. Email: iwiesen@wiesenlaw.com Phone: (212) 3818774

Related Public Records

Same Entity

Cair LGL

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014498869	Cair LGL	Saint Laurent de Chamousset Rhone, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
3018229072	INNOVATIVE HEALTH SCIENCES	Chester, NY, US
3030989877	INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL	Sun Valley, CA, US
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005458990. Last updated year: 2026. Please use registration number 3005458990 when referencing this establishment in official correspondence.