HAEMONETICS CORPORATION

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1219343	1219343	HAEMONETICS CORPORATION	1	Y	2026-01-01	125 Summer Street Boston MA US 02110
3011538588	3011538588	Haemonetics Malaysia Sdn Bhd	1	N	2026-01-01	PMT 727, Persiaran Cassia Selatan 1 Taman Perindustrian Batu Kawan,14100 Simpang Amp Penang Pulau Pinang MY .
3011773324	3011773324	Haemonetics Corporation	1	Y	2026-01-01	1555 South Gramercy Rd Ste 500 Salt Lake City UT US 84104
3019849102	3019849102	Haemonetics Corporation	1	Y	2026-01-01	1300 Clifford Ball Drive Clinton PA US 15026
2013342	2013342	HAEMONETICS MANUFACTURING INC.	1	N	2020-04-25	1630 INDUSTRIAL PARK ST. COVINA CA US 91722
2529337	1000121528	HAEMONETICS CORPORATION	1	N	2020-04-25	BUNCHER INDUSTRIAL PARK AVENUE C, BUILDING 18 LEETSDALE PA US 15056
3008061061	3008061061	Haemonetics Corporation	1	N	2020-04-25	12046 Lone Peak Parkway Draper UT US 84020
3009762306	3009762306	Haemonetics Puerto Rico, LLC	1	N	2020-04-25	Carr 194, Pall Boulevard #98 Fajardo PR US 00738
3010886691	3010886691	Haemonetics Corporation	1	Y	2020-04-25	549 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 GUDID	Product	Phone	Email
00812747018596	Antiplatelet Reagent - ANTIPLATELET REAGENT, US	+1(800)-537-2802	pirdesk@Haemonetics.com
00812747019807	Haemonetics® NexSys PCS® System - Persona™ Plasma Pooling Bottles	+1(800)-537-2802	pirdesk@Haemonetics.com
00812747019814	Haemonetics® NexSys PCS® System - Persona™ Plasma Pooling Bottles	+1(800)-537-2802	pirdesk@Haemonetics.com

haemonetics.com

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
30141	1579164740	K993678	THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES	JPA	2000-05-05
30143	1579164740	K993678	THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES	JPA	2000-05-05
294946	1579164740	K993678	THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES	JPA	2000-05-05
30141	2027349207	K992723	ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM	CAC	1999-10-18
30141	1492018481	K962475	ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM	CAC	1997-02-20
30141	1776442348	K960993	PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)	CAK	1996-04-22
144411	1776442348	K960993	PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)	CAK	1996-04-22
30141	1209007533	K953681	HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET	LKN	1996-06-04
30141	2037464588	K932890	CELL SAVER 5 SYSTEM	CAC	1994-01-05
187777	2037464588	K932890	CELL SAVER 5 SYSTEM	CAC	1994-01-05
30141	1853575207	K883934	CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM	CAC	1988-12-27
30141	1223224870	K875095	PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE	JOD	1988-02-29
144411	1223224870	K875095	PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE	JOD	1988-02-29
30141	1153678599	K873667	PALL LEUKOCYTE REMOVAL FILTER, PLATELETS	CAK	1988-01-06
144375	1153678599	K873667	PALL LEUKOCYTE REMOVAL FILTER, PLATELETS	CAK	1988-01-06
30141	1459786263	K873666	PALL LEUKOCYTE REMOVAL FILTER, BLOOD	CAK	1988-01-06
144375	1459786263	K873666	PALL LEUKOCYTE REMOVAL FILTER, BLOOD	CAK	1988-01-06
30141	1385891962	K852645	FLUID MANAGEMENT SYSTEM	FRN	1985-12-09
144375	1341018030	K850825	AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR	FPB	1985-04-09
30141	1985626691	K251024	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge	JPA	2025-04-30
294946	1985626691	K251024	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge	JPA	2025-04-30
30141	1136943428	K243858	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge	JPA	2025-01-15
294946	1136943428	K243858	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge	JPA	2025-01-15
30141	1084329710	K232018	Citrated: K, KH, RTH, FFH	JPA	2024-03-29
294946	1084329710	K232018	Citrated: K, KH, RTH, FFH	JPA	2024-03-29
30141	1055645672	K221722	Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)	CAC	2022-11-15
30141	2058233378	K183160	TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge	JPA	2019-05-09
30143	2058233378	K183160	TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge	JPA	2019-05-09
294946	2058233378	K183160	TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge	JPA	2019-05-09
30141	1180693271	K162423	Haemonetics Cell Saver Elite/Elite+ Autotransfusion System	CAC	2017-01-03
30141	1388160497	K150041	CORA (Coagulation Resonance Analysis) System	JPA	2015-06-26
30143	1388160497	K150041	CORA (Coagulation Resonance Analysis) System	JPA	2015-06-26
294946	1388160497	K150041	CORA (Coagulation Resonance Analysis) System	JPA	2015-06-26
30141	1354314330	K140893	CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY	JOZ	2015-01-03
30143	1354314330	K140893	CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY	JOZ	2015-01-03
294946	1354314330	K140893	CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY	JOZ	2015-01-03
30141	1551666901	K122262	ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM	CAC	2012-10-25
30141	1549539943	K120586	CELL SAVER ELITE	CAC	2012-05-22
30141	2016592179	K101907	HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM	CAC	2010-12-03
187777	2016592179	K101907	HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM	CAC	2010-12-03
30141	1991739884	K062604	RAPIDTEG TEG-ACT TEST	JBP	2007-01-31
30143	1991739884	K062604	RAPIDTEG TEG-ACT TEST	JBP	2007-01-31
294946	1991739884	K062604	RAPIDTEG TEG-ACT TEST	JBP	2007-01-31
30141	1559783554	K061103	HAEMONETICS 40U RBC FILTER BAG	CAK	2006-05-17
30141	1573852465	K053000	HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)	CAC	2005-11-21
30141	1580981363	K052626	SMARTSUCTION HARMONY DEVICE	BTA	2005-10-05
30141	1681805156	K043127	HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM	CAC	2005-01-04
30141	1192074546	K041502	THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY	JOZ	2004-09-01
30143	1192074546	K041502	THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY	JOZ	2004-09-01
294946	1192074546	K041502	THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY	JOZ	2004-09-01
30141	2059326047	K014083	HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM	CAC	2002-01-08
30141	1343272730	K002177	THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES	JPA	2000-09-14
30143	1343272730	K002177	THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES	JPA	2000-09-14
294946	1343272730	K002177	THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES	JPA	2000-09-14
30141	1703692491	BK990033
30141	1063971439	BK990022
30141	2052424152	BK950059
30141	1923952079	BK950033
30143	1923952079	BK950033
109264	1923952079	BK950033
179610	1923952079	BK950033
294946	1923952079	BK950033
30141	1259979269	BK920039
179610	1259979269	BK920039
30141	1835261051	BK920023
144375	1835261051	BK920023
30141	1819912464	BK910019
144375	1819912464	BK910019
30141	1096556559	BK870026
179610	1096556559	BK870026
144375	1837736020	BK860040
144375	1057399184	BK860028
144375	1067733453	BK850026
144375	1307755715	BK840010
30141	1494347392	BK251292
30141	1830935869	BK251241
30141	1073653029	BK241062
30141	1262675396	BK231036
30141	2053773817	BK220798
179610	2053773817	BK220798
187777	2053773817	BK220798
294946	2053773817	BK220798
30141	1455254052	BK200498
30141	1188884425	BK180209
30141	1603786065	BK180185
294946	1603786065	BK180185
30141	1523961566	BK170045
30141	1639500874	BK160052
144375	1909159919	BK160027
30141	1158759004	BK160019
30141	1046977571	BK150360
30141	1502111364	BK150330
30141	1387704212	BK150308
30141	1303025276	BK150292
30141	1556118179	BK140199
30141	1853981169	BK140183
30141	1969248278	BK140166
30141	1363086008	BK140133
30141	1197460100	BK130082
30141	1264844476	BK120084
30141	1729073010	BK120065
30141	1288566186	BK110015
30141	1828710085	BK100002
30141	1995150732	BK090063
30141	1284857181	BK090041
30141	1483655683	BK090033
30141	1750531720	BK090026
144375	1512672647	BK090007
30141	1946541913	BK090004
30141	1583218097	BK080038
30141	1888384093	BK080025
30141	1659428149	BK080014
144375	2029832202	BK080003
30141	1398093942	BK080001
30141	1497312283	BK070064
144375	1547991759	BK070063
30141	1086800255	BK070031
30141	1829204897	BK060057
144375	1633188549	BK060045

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
JPA	19	2025-04-30
CAC	14	2022-11-15
CAK	7	2006-05-17
JOZ	6	2015-01-03
JBP	3	2007-01-31
JOD	2	1988-02-29
BTA	1	2005-10-05
LKN	1	1996-06-04
FRN	1	1985-12-09
FPB	1	1985-04-09

PMN

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

2025-01-15

Haemonetics Corporation

Citrated: K, KH, RTH, FFH

2024-03-29

Haemonetics Corporation

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)

2022-11-15

Haemonetics Corporation

Automated Blood Cell Separators

2020-10-02

Haemonetics Corporation

TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge

2019-05-09

Haemonetics Corporation

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2018-08-07

Haemonetics Corporation

Automated Blood Cell Separators

2018-03-27

Haemonetics Corporation

Automated Blood Cell Separators

2017-07-25

Haemonetics Corporation

TEG 6s Hemostasis System

2017-04-19

Haemonetics Corporation

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System

2017-01-03

HAEMONETICS CORPORATION

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2016-08-25

Haemonetics Corporation

Haemonetics Cell Saver Elite Autotransfusion System

2016-05-24

Haemonetics Corporation

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2016-05-17

Haemonetics Corporation

Empty Containers For The Collection & Processing Of Blood/Blood Components

2016-05-16

Haemonetics Manufacturing Inc.

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2016-03-11

Haemonetics Corporation

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2016-03-03

Haemonetics Corporation Software Solutions

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2015-11-20

Haemonetics Corporation Software Solutions

Automated Blood Cell Separators

2015-07-28

Haemonetics Corporation

Automated Blood Cell Separators

2015-07-28

Haemonetics Corporation

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2015-02-05

Haemonetics Corporation

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2014-12-10

Haemonetics Corporation Software Solutions

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2014-10-10

Haemonetics Corporation Software Solutions

Automated Blood Cell Separators

2014-08-29

Haemonetics Corporation

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2014-08-29

Haemonetics Corporation Software Solutions

Automated Blood Cell Separators

2014-08-26

Haemonetics Corporation

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2014-08-08

Haemonetics Corporation

Automated Blood Cell Separators

2014-01-23

Haemonetics Corporation

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2013-04-30

Haemonetics Corporation

Automated Blood Cell Separators

2013-03-20

Haemonetics Corporation

Automated Blood Cell Separators

2012-11-26

Haemonetics Corporation

ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM

2012-10-25

HAEMONETICS CORP.

CELL SAVER ELITE

2012-05-22

HAEMONETICS CORP.

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2011-06-13

Haemonetics Corporation

HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM

2010-12-03

HAEMONETICS CORP.

Automated Blood Cell Separators

2010-01-27

Haemonetics Corporation

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2009-09-28

Haemonetics Corporation

Empty Containers For The Collection & Processing Of Blood/Blood Components

2009-02-25

Haemonetics Manufacturing Inc.

Automated Blood Cell Separators

2009-02-20

Haemonetics Corporation Software Solutions

Automated Blood Cell Separators

2008-09-04

Haemonetics Corporation Software Solutions

Automated Blood Cell Separators

2008-08-15

Haemonetics Corporation

135 records. Showing 1-40. Next

Applications

076316

HAEMONETICS

GUDID

Haemonetics® NexSys PCS® System - PLS Harness Set

HAEMONETICS CORPORATION

2026-03-20

Haemonetics® NexSys PCS® System - Persona™ Plasma Pooling Bottles

HAEMONETICS CORPORATION

2025-07-16

TEG6s HEMOSTASIS SYSTEM - CITRATED: K, KH, RT, FF

HAEMONETICS CORPORATION

2017-04-25

HAEMONETICS CELL SAVER ELITE+ SYSTEM - CSE-EX-US

HAEMONETICS CORPORATION

2025-06-12

Antiplatelet Reagent - ANTIPLATELET REAGENT, US

HAEMONETICS CORPORATION

2025-05-20

Haemonetics® NexSys PCS® System - Persona™ Plasma Pooling Bottles

HAEMONETICS CORPORATION

2024-10-10

Haemonetics® PCS®2 & NexSys PCS® Systems - PLS HARNESS SET

HAEMONETICS CORPORATION

2024-07-19

Haemonetics® PCS®2 & NexSys PCS® Systems - PLS HARNESS SET

HAEMONETICS CORPORATION

2024-07-19

Haemonetics® NexSys PCS® System - 0625Q-00 Plasma Bowl

HAEMONETICS CORPORATION

2024-07-17

Global Hemostasis - HN - CITRATED: K, KH, RTH, FFH

HAEMONETICS CORPORATION

2024-04-10

MCS+ (LN8150) RBC APHERESIS - 2 UNIT RED CELL SET W/RC2H FIL

HAEMONETICS CORPORATION

2017-02-08

HAEMONETICS ACP 215 SYSTEM - RBC GLYCEROLIZATION SET

HAEMONETICS CORPORATION

2017-02-07

HAEMONETICS ACP 215 SYSTEM - RBC DE-GLYCEROL./CELL WASH SET

HAEMONETICS CORPORATION

2017-02-07

HAEMONETICS ACP 215 SYSTEM - RBC DE-GLYCEROL. SET 325ML BMB

HAEMONETICS CORPORATION

2017-02-07

TEG HEMOSTASIS SYSTEM - CALCIUM CHLORIDE, 0.2M, 5 ML

HAEMONETICS CORPORATION

2017-07-31

Haemonetics® NexSys PCS® System - 0625Q-00 Plasma Bowl

HAEMONETICS CORPORATION

2023-06-29

MCS 9000 - 09000-220-ED

HAEMONETICS CORPORATION

2023-02-07

Haemonetics® PCS®2, NexSys PCS® & MCS®+ Systems - PLS Bag w/Vac Sampling

HAEMONETICS CORPORATION

2022-10-26

TEG5000 - PIPETTE KIT, 100UL

HAEMONETICS CORPORATION

2017-05-30

TEG5000 - PIPETTE KIT, 1000UL

HAEMONETICS CORPORATION

2017-03-13

TEG5000 - ELECTRONIC PIPPETTE KIT, 1000UL

HAEMONETICS CORPORATION

2017-07-17

Haemonetics - FILTER RC EZ PRIME W/S SET

HAEMONETICS CORPORATION

2022-03-15

Haemonetics - High Efficiency Leukocyte Reduction Filter for Platelets with Attached Straight Administration Set

HAEMONETICS CORPORATION

2022-03-15

Haemonetics TEG 6s - Reagent QC Level 2

HAEMONETICS CORPORATION

2021-06-18

Hemostasis System - Citrated: K, RT, FF

HAEMONETICS CORPORATION

2021-06-17

Haemonetics TEG 6s - Reagent QC Level 1 US

HAEMONETICS CORPORATION

2021-06-17

Haemonetics - Blood Transfusion Filter

HAEMONETICS CORPORATION

2021-03-19

HAEMONETICS CELL SAVER 5/5+ SYSTEM - HIGH SPEED CELL SAVER5/5+BOWL SET

HAEMONETICS CORPORATION

2015-09-24

HAEMONETICS CELL SAVER 5/5+ SYSTEM - CELL SAVER 5/5+ BOWL SET (70ML)

HAEMONETICS CORPORATION

2015-09-24

HAEMONETICS CELL SAVER SYSTEMS - RBC BAG WITH LUER LOCK, 600ML

HAEMONETICS CORPORATION

2017-02-28

HAEMONETICS CELL SAVER SYSTEMS - WASTE BAG, 5L

HAEMONETICS CORPORATION

2017-02-28

HAEMONETICS CELL SAVER SYSTEM - Y CONNECTOR WITH CHECK VALVE

HAEMONETICS CORPORATION

2015-09-24

HAEMONETICS CELL SAVER SYSTEM - RESERVOIR,HARDSHELL,150 µ_ Note: Additional packaging DI: 20812747016039, Unit Packaging, contains (1) 10812747016032 DI:30812747016036, carton contains (4) 20812747016039

HAEMONETICS CORPORATION

2017-08-16

HAEMONETICS CELL SAVER SYSTEM - ASPIRATION/ANTICOAGULATION SET

HAEMONETICS CORPORATION

2017-08-16

HAEMONETICS CELL SAVER SYSTEM - RESERVOIR, HARD-SHELL, 20µ_ Additional packaging DI: 20812747016060, Unit packaging, contains (1) 1082747016063

HAEMONETICS CORPORATION

2017-06-16

HAEMONETICS CELL SAVER SYSTEM - Y SET WITH EXTENSION LINE

HAEMONETICS CORPORATION

2015-09-24

HAEMONETICS CELL SAVER SYSTEMS - RBC BAG W/TWIST LOCK, 1000ML

HAEMONETICS CORPORATION

2017-06-27

HAEMONETICS CELL SAVER 5/5+ SYSTEMS - 10 LITER WASTE BAG

HAEMONETICS CORPORATION

2017-06-27

HAEMONETICS CELL SAVER 5/5+ SYSTEMS - CS5/5+ FASTPACK, 225ML 150U RES

HAEMONETICS CORPORATION

2015-09-24

HAEMONETICS CELL SAVER 5/5+ SYSTEMS - CELL SAVER 5/5+ BOWL KIT-125ML

HAEMONETICS CORPORATION

2015-09-24

167 records. Showing 1-40. Next