HAEMONETICS CORPORATION

Matched from indexed company URL: Haemonetics Corporation

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
12193431219343HAEMONETICS CORPORATION1Y2026-01-01125 Summer Street Boston MA US 02110
30115385883011538588Haemonetics Malaysia Sdn Bhd1N2026-01-01PMT 727, Persiaran Cassia Selatan 1 Taman Perindustrian Batu Kawan,14100 Simpang Amp Penang Pulau Pinang MY .
30117733243011773324Haemonetics Corporation1Y2026-01-011555 South Gramercy Rd Ste 500 Salt Lake City UT US 84104
30198491023019849102Haemonetics Corporation1Y2026-01-011300 Clifford Ball Drive Clinton PA US 15026
20133422013342HAEMONETICS MANUFACTURING INC.1N2020-04-251630 INDUSTRIAL PARK ST. COVINA CA US 91722
25293371000121528HAEMONETICS CORPORATION1N2020-04-25BUNCHER INDUSTRIAL PARK AVENUE C, BUILDING 18 LEETSDALE PA US 15056
30080610613008061061Haemonetics Corporation1N2020-04-2512046 Lone Peak Parkway Draper UT US 84020
30097623063009762306Haemonetics Puerto Rico, LLC1N2020-04-25Carr 194, Pall Boulevard #98 Fajardo PR US 00738
30108866913010886691Haemonetics Corporation1Y2020-04-25549 Aldi Blvd Mount Juliet TN US 37122

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00812747018596Antiplatelet Reagent - ANTIPLATELET REAGENT, US+1(800)-537-2802pirdesk@Haemonetics.com
00812747019807Haemonetics® NexSys PCS® System - Persona™ Plasma Pooling Bottles+1(800)-537-2802pirdesk@Haemonetics.com
00812747019814Haemonetics® NexSys PCS® System - Persona™ Plasma Pooling Bottles+1(800)-537-2802pirdesk@Haemonetics.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
301411579164740K993678THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIESJPA2000-05-05
301431579164740K993678THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIESJPA2000-05-05
2949461579164740K993678THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIESJPA2000-05-05
301412027349207K992723ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEMCAC1999-10-18
301411492018481K962475ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEMCAC1997-02-20
301411776442348K960993PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)CAK1996-04-22
1444111776442348K960993PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)CAK1996-04-22
301411209007533K953681HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SETLKN1996-06-04
301412037464588K932890CELL SAVER 5 SYSTEMCAC1994-01-05
1877772037464588K932890CELL SAVER 5 SYSTEMCAC1994-01-05
301411853575207K883934CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEMCAC1988-12-27
301411223224870K875095PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANEJOD1988-02-29
1444111223224870K875095PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANEJOD1988-02-29
301411153678599K873667PALL LEUKOCYTE REMOVAL FILTER, PLATELETSCAK1988-01-06
1443751153678599K873667PALL LEUKOCYTE REMOVAL FILTER, PLATELETSCAK1988-01-06
301411459786263K873666PALL LEUKOCYTE REMOVAL FILTER, BLOODCAK1988-01-06
1443751459786263K873666PALL LEUKOCYTE REMOVAL FILTER, BLOODCAK1988-01-06
301411385891962K852645FLUID MANAGEMENT SYSTEMFRN1985-12-09
1443751341018030K850825AEF POSIDYNE I.V. FILTER/AIR ELIMINATORFPB1985-04-09
301411985626691K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA2025-04-30
2949461985626691K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA2025-04-30
301411136943428K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA2025-01-15
2949461136943428K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA2025-01-15
301411084329710K232018Citrated: K, KH, RTH, FFHJPA2024-03-29
2949461084329710K232018Citrated: K, KH, RTH, FFHJPA2024-03-29
301411055645672K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC2022-11-15
301412058233378K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeJPA2019-05-09
301432058233378K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeJPA2019-05-09
2949462058233378K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeJPA2019-05-09
301411180693271K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemCAC2017-01-03
301411388160497K150041CORA (Coagulation Resonance Analysis) SystemJPA2015-06-26
301431388160497K150041CORA (Coagulation Resonance Analysis) SystemJPA2015-06-26
2949461388160497K150041CORA (Coagulation Resonance Analysis) SystemJPA2015-06-26
301411354314330K140893CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAYJOZ2015-01-03
301431354314330K140893CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAYJOZ2015-01-03
2949461354314330K140893CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAYJOZ2015-01-03
301411551666901K122262ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEMCAC2012-10-25
301411549539943K120586CELL SAVER ELITECAC2012-05-22
301412016592179K101907HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEMCAC2010-12-03
1877772016592179K101907HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEMCAC2010-12-03
301411991739884K062604RAPIDTEG TEG-ACT TESTJBP2007-01-31
301431991739884K062604RAPIDTEG TEG-ACT TESTJBP2007-01-31
2949461991739884K062604RAPIDTEG TEG-ACT TESTJBP2007-01-31
301411559783554K061103HAEMONETICS 40U RBC FILTER BAGCAK2006-05-17
301411573852465K053000HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)CAC2005-11-21
301411580981363K052626SMARTSUCTION HARMONY DEVICEBTA2005-10-05
301411681805156K043127HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEMCAC2005-01-04
301411192074546K041502THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAYJOZ2004-09-01
301431192074546K041502THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAYJOZ2004-09-01
2949461192074546K041502THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAYJOZ2004-09-01
301412059326047K014083HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEMCAC2002-01-08
301411343272730K002177THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIESJPA2000-09-14
301431343272730K002177THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIESJPA2000-09-14
2949461343272730K002177THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIESJPA2000-09-14
301411703692491BK990033
301411063971439BK990022
301412052424152BK950059
301411923952079BK950033
301431923952079BK950033
1092641923952079BK950033
1796101923952079BK950033
2949461923952079BK950033
301411259979269BK920039
1796101259979269BK920039
301411835261051BK920023
1443751835261051BK920023
301411819912464BK910019
1443751819912464BK910019
301411096556559BK870026
1796101096556559BK870026
1443751837736020BK860040
1443751057399184BK860028
1443751067733453BK850026
1443751307755715BK840010
301411494347392BK251292
301411830935869BK251241
301411073653029BK241062
301411262675396BK231036
301412053773817BK220798
1796102053773817BK220798
1877772053773817BK220798
2949462053773817BK220798
301411455254052BK200498
301411188884425BK180209
301411603786065BK180185
2949461603786065BK180185
301411523961566BK170045
301411639500874BK160052
1443751909159919BK160027
301411158759004BK160019
301411046977571BK150360
301411502111364BK150330
301411387704212BK150308
301411303025276BK150292
301411556118179BK140199
301411853981169BK140183
301411969248278BK140166
301411363086008BK140133
301411197460100BK130082
301411264844476BK120084
301411729073010BK120065
301411288566186BK110015
301411828710085BK100002
301411995150732BK090063
301411284857181BK090041
301411483655683BK090033
301411750531720BK090026
1443751512672647BK090007
301411946541913BK090004
301411583218097BK080038
301411888384093BK080025
301411659428149BK080014
1443752029832202BK080003
301411398093942BK080001
301411497312283BK070064
1443751547991759BK070063
301411086800255BK070031
301411829204897BK060057
1443751633188549BK060045

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
JPA192025-04-30
CAC142022-11-15
CAK72006-05-17
JOZ62015-01-03
JBP32007-01-31
JOD21988-02-29
BTA12005-10-05
LKN11996-06-04
FRN11985-12-09
FPB11985-04-09

PMN

135 records. Showing 1-40. Next

Applications

GUDID

167 records. Showing 1-40. Next