Haemonetics Mexico Manufacturing S De R L De C V

FDA Filings

This page includes the latest FDA filings for Haemonetics Mexico Manufacturing S De R L De C V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9617787
• FEI Number: 3003327833
• Name: Haemonetics Mexico Manufacturing S. de R.L. de C.V.
• Owner & Operator: Haemonetics Corporation
• Contact Address: 125 Summer St ; Boston MA 02110 US
• Official Correspondent:
  • Julie A Ryan
  • 1-781-3569682-x
• US Agent:
  • Julie A Ryan
  • HAEMONETICS CORPORATION
  • 781 3569682
  • 781 3563558
  • julie.ryan@haemonetics.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Calle Colinas No. 11731 Secc. Colinas Parque Industrial el Florido; TIJUANA, B.C. Mexico, C.P. 22244 MX
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN BK160027 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Acrodose PL and PLus Systems	2018-05-08
PMN K850825 | FPB Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Posidyne NEO	2016-07-20
PMN K883934 | CAC Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Cell Saver	2015-08-20
PMN K852645 | FRN Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	R.I.S.	2015-08-20
PMN K962475 | CAC Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	OrthoPAT	2015-06-24
PMN K043127 | CAC Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	cardioPAT	2015-06-24
PMN BK980038 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Pall Cell Wash Infusion Set	2014-04-09
PMN BK980030 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Pall Freezing Bag	2014-04-09
PMN BK980027 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Pall Transfer - Freezing Bag Set	2014-04-09
PMN BK100058 | ORG Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Pall Celeris fPC Platelet Concentration System	2014-04-09
PMN K932890 | CAC Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Cell Saver Elite	2014-01-16
PMN K932890 | CAC Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Cell Saver 5, Cell Saver 5+	2014-01-16
PMN BK870026 | GKT Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	PCS2	2014-01-09
PMN BK870026 | GKT Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	NexSys PCS	2014-01-09
PMN BK120083 | GKT Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Red Blood Cells & Plasma Disposable Set w/RBC LR Filter	2013-11-21
PMN K122262 | CAC Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	OrthoPAT advance	2012-11-13
HXD Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Pinch Clamp	2012-08-24
PMN K873667 | CAK Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Leukocyte Removal Filter Systems - Platelets	2012-08-09
PMN K873666 | CAK Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Leukocyte Removal Filter Systems - Whole Blood	2012-08-09
PMN BK920023 | GKT Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Autostop LR Platelet Filter Systems	2012-08-09
PMN BK910019 | CAK Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Leukocyte Removal Blood Processing Filter Systems	2012-08-09
PMN BK860040 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Blood Collection Unit w/out Anticoagulant	2012-08-09
PMN BK860028 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Component Aliquot Systems	2012-08-09
PMN BK850026 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Neocel Systems	2012-08-09
PMN BK840010 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Transfer Bags	2012-08-09
PMN BK090007 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	6;1 Connector - Acrodose Systems	2012-08-09
PMN BK080003 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Acrodose PLus Systems	2012-08-09
PMN BK070063 | MZC Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	eBDS Sample Set	2012-08-09
PMN BK060045 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Acrodose PL w/out eBDS	2012-08-09
PMN BK060044 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Acrodose PL w/eBDS	2012-08-09
PMN BK050015 | CAK Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Leukotrap SC RC Filtration Systems	2012-08-09
PMN BK000032 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Plasma Bag	2012-08-09
PMN K101907 | CAC Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Cell Saver Elite	2011-01-24
PMN BK060057 | GKT Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Cymbal	2011-01-24
PMN K953681 | LKN Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	THERAPEUTIC PLASMA EXCHANGE SET	2010-06-22
PMN BK060023 | GKT Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	MCS+8150 Apheresis System	2010-06-17
PMN BK050048 | GKT Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	MCS+8150 Apheresis System	2010-06-17
PMN BK050047 | GKT Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	MCS+9000, SDP revision E software, 994CF-CPP series disposable sets	2010-04-30
PMN BK020001 | KSR Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	PCS2, PCS 300, NexSys PCS	2009-10-20
PMN K053000 | CAC Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	cardioPAT	2008-11-06
PMN K052626 | BTA Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	SmartSuction Harmony	2008-11-06
PMN K014083 | CAC Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Cell Saver 5	2008-11-06
PMN BK080001 | GKT Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	PCS2	2008-11-06
PMN BK080001 | GKT Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	PCS2 with Rev K Software	2008-11-06
PMN BK060008 | KSW Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	Haemonetics Model 215 Automated Glycerolization/Deglycerolization and Cell Washing System	2008-11-06
PMN BK060008 | KSW Haemonetics Mexico Manufacturing S. de R.L. de C.V. [Haemonetics Corporation]	ACP215	2008-11-06