Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017088037

FEI Number

3017088037

Entity Name

OUTSOURCING FARM LA, CORP

City/State/Country

Panama, PA

Establishment Address

Calle 8va. Galera Corregimiento Rio Abajo 22, Panama, Panama, Panama, Panama 0801-01201, PA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Outsourcing Farm LA, Corp (Owner Number: 10095149)

Owner / Operator Contact Address

Calle 8va. Galera Corregimiento Rio Abajo 22, Panama, Panama, Panama, Panama, PA-8 0801-01201, PA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121511

PMA Number

N/A

All Registered Proprietary Names

JR-024M Tubo de Extension con Valvula de Inyeccion Libre de Aguja - Biosite Extension Bifurcado Adulto JR-011M Equipo de Infusion con Valvula Libre de Aguja - Biosite Macro Gotero JR-012-AU Biosite Volumetric Set - 100 mL JR-009-HU 300 PSI High-Pressure Needleless Neutral Valve JR-016-AU Biosite Pediatric Extension Tube JR-009M Equipo de Infusion con Valvula Libre de Aguja - Valvula Neutra Libre de Aguga 60 psi JR-025-BU Biosite with Flow Control JR-018-N Tubo de Extension con Valvula de Inyeccion Libre de Aguja - Biosite Neonato Luer Slip JR-011-AU Biosite Regular Set JR-024-MB Biosite Adult Bifurcated Extension Tube Microbore JR-045M Euipo de Infusion con Valvula Libre de Aguja - Biosite con Espiga de Traseegar JR-017M Tubo de Extension con Valvula de Inyeccion Libre de Aguja - Biosite con Filtro para Solucion JR-015-AU Biosite Surgical Set with Check Valve JR-011-BU Biosite Regular Set JR-044-AU Biosite Transfer Spike JR-009-AU 60 PSI Needleless Neutral Valve JR-014-AU Biosite Adult Extension Tube JR-044M Equipo de Infusion con Valvula Libre de Aguja - Biosite con Espiga de Tranferencia JR-019-AU Biosite Extension with Nutrition Filter JR-032-LU Biosite Pediatric Trifurcated Extension Tube JR-014M Tubo de Extension con Valvula de Inyeccion Libre de Aguja - Biosite Tubo de Extension Adulto JR-033-SU Biosite Neonatal Trifurcated Extension Tube JR-012M Equipo de Infusion con Valvula Libre de Aguja - Biosite Set Volumetrico JR-010M Equipo de Infusion con Valvula Libre de Aguja - Biosite Macro Quirurgico JR-011-RU Biosite Regular Set JR-020-LU Biosite Pediatric Bifurcated Extension Tube - Luer Lock JR-015-BU Biosite Surgical Set with Check Valve JR-013-RU Biosite Microdrip with Flow Control JR-021-N Tubo de Extension con Valvula de Inyeccion Libre de Aguja - Biosite Extension Bifurcado Neonato Luer Slip JR-025M Tubo de Extension con Valvula de Inyeccion Libre de Aguja - Biosite con Dosidificador JR-010-AU Biosite Surgical Set JR-018-SU Biosite Neonatal Extension Tube - Luer Slip JR-016M Tubo de Extension con Valvula de Inyeccion Libre de Aguja - Biosite Tubo de Extension Pediatrico JR-009-TU 60 PSI Transparent Needleless Neutral Valve JR-013M Equipo de Infusion con Valvula Libre de Aguja - Biosite Microgotero JR-021-LU Biosite Neonatal Bifurcated Extension Tube - Luer Lock JR-012-CU Biosite Volumetric Set - 150 mL JR-019M Tubo de Extension con Valvula de Inyeccion Libre de Aguja - Biosite con Filtro para Nutricion JR-021-SU Biosite Neonatal Bifurcated Extension Tube - Luer Slip JR-020-SU Biosite Pediatric Bifurcated Extension Tube - Luer Slip JR-010-RU Biosite Surgical Set JR-015M Euipo de Infusion con Valvula Libre de Aguja - Biosite Macrogotero Quirurgico con Valvula Antireflujo JR-010-BU Biosite Surgical Set JR-031-AU Biosite Adult Trifurcated Extension Tube JR-025-AU Biosite with Flow Control JR-017-AU Biosite Extension with Solution Filter JR-020M Tubo de Extension con Valvula de Inyeccion Libre de Aguja - Biosite Extension Bifurcado Pediatrico JR-018-LU Biosite Neonatal Extension Tube - Luer Lock JR-013-AU Biosite Microdrip JR-024-AU Biosite Adult Bifurcated Extension Tube

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	2026-01-28

Official Correspondent

No official correspondent registered.

US Agent Details

Herschel Gaddy Business: Herschel J. Gaddy & Associates Email: herschel.gaddy@gaddyandassociates.com Phone: (816) 2323856

Related Public Records

Same Entity

Outsourcing Farm LA, Corp

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

View Entity Profile →

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 3017088037. Last updated year: 2026. Please use registration number 3017088037 when referencing this establishment in official correspondence.