Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617787

FEI Number

3003327833

Entity Name

Haemonetics Mexico Manufacturing S. de R.L. de C.V.

City/State/Country

TIJUANA, B.C. Mexico, MX

Establishment Address

Calle Colinas No. 11731 Secc. Colinas, Parque Industrial el Florido, TIJUANA, B.C. Mexico C.P. 22244, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Haemonetics Corporation (Owner Number: 1219343)

Owner / Operator Contact Address

125 Summer St, Boston, MA 02110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK060008

PMA Number

N/A

All Registered Proprietary Names

PCS2 NexSys PCS Red Blood Cells & Plasma Disposable Set w/RBC LR Filter THERAPEUTIC PLASMA EXCHANGE SET Cell Saver 5, Cell Saver 5+ Cell Saver Elite MCS+8150 Apheresis System SmartSuction Harmony Cell Saver 5 Cell Saver Elite Cymbal MCS+8150 Apheresis System R.I.S. Haemonetics Model 215 Automated Glycerolization/Deglycerolization and Cell Washing System ACP215

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-01-09
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2013-11-21
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2010-06-22
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2014-01-16
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2010-06-17
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2008-11-06
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2008-11-06
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2011-01-24
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2011-01-24
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2010-06-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2015-08-20
KSW	System, Processing For Frozen Blood	Hematology	Class 2	864.9145	2008-11-06

Official Correspondent

Julie Ryan

US Agent Details

Julie A Ryan Business: HAEMONETICS CORPORATION Email: julie.ryan@haemonetics.com Phone: (781) 6900575

Related Public Records

Same Entity

Haemonetics Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011773324	Haemonetics Corporation	Salt Lake City, UT, US
3011538588	Haemonetics Malaysia Sdn Bhd	Penang Pulau Pinang, MY
3019849102	Haemonetics Corporation	Clinton, PA, US
1219343	HAEMONETICS CORPORATION	Boston, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881350	Stryker Corp.	CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM	1988-09-30
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
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
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617787. Last updated year: 2026. Please use registration number 9617787 when referencing this establishment in official correspondence.