FDA.reportPublic FDA data

Hemostasis System

Primary DI
10812747018463
Brand
Hemostasis System
Company
HAEMONETICS CORPORATION
Model
07-605-US
Device description
Citrated: K, RT, FF
Published
2021-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPASystem, Multipurpose For In Vitro Coagulation StudiesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183160000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183160000TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeHaemonetics Corporation2019-05-09JPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20812747018460PackageGS110In Commercial Distribution
10812747018463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081274701846020812747018460
1081274701846310812747018463

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation marker IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated components, functional tests [activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT)] and/or physiological anticoagulants (e.g., antithrombin III) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)-537-2802pirdesk@Haemonetics.com

Regulatory Flags#

DUNS number
057827420
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812747018203TEG500007-0442017-05-30
10812747018210TEG500007-0452017-05-30
10812747018296TEG6s HEMOSTASIS SYSTEM07-650-US2017-07-17
10812747018302TEG6s HEMOSTASIS SYSTEM07-651-US2017-08-18
10812747018326TEG6s HEMOSTASIS SYSTEM07-601-US2017-04-25
10812747018340TEG6S HEMOSTASIS SYSTEM07-662US2017-07-17
10812747018531Global Hemostasis - HN07-604-US2024-04-10
20812747018491Haemonetics TEG 6s07-664-US2021-06-17
20812747018514Haemonetics TEG 6s07-665US2021-06-18
20812747018002TEG5000 HEMOSTASIS SYSTEM07-0042017-06-16
20812747018019TEG5000 HEMOSTASIS SYSTEM07-0062017-06-16
20812747018026TEG5000 HEMOSTASIS SYSTEM07-0072017-06-16
20812747018033TEG5000 HEMOSTASIS SYSTEM07-0082017-06-16
10812747019859Haemonetics® NexSys PCS® System00620-NX2026-03-20
30812747019853Haemonetics® NexSys PCS® System00620-NX2026-03-20
30812747011659HAEMONETICS PCS 300 PLASMA COLLECTION SYSTEMPCS-300-US2017-11-01
10887691000116HaemoneticsPL1B2016-12-15
10887691000161Haemonetics EZ PrimeRCEZ1T2016-12-15
10887691000178HaemoneticsRCEZKS2022-03-15
10887691000192PL High Efficiency Leukocyte Reduction FilterPL6T2016-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000558185CLOTtrac™MEDTRONIC, INC.JPA2026-02-22
00763000558291RACTMEDTRONIC, INC.JPA2026-02-22
20763000558189CLOTtrac™MEDTRONIC, INC.JPA2026-02-22
20763000558295RACTMEDTRONIC, INC.JPA2026-02-22
04987562499700Automated Blood Coagulation Analyzer CN-3000SYSMEX CORPORATIONJPA2025-12-19
04987562518616Automated Blood Coagulation Analyzer CN-3000SYSMEX CORPORATIONJPA2025-12-19
08426951011223HemosIL CL TriggersINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08426951326594HemosIL CL Rinse solutionINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08430793045476ACL TOP 970 CLINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
08430793058322HemosIL CL Probe ConditionerINSTRUMENTATION LABORATORY COMPANYJPA2025-10-02
04987562499687Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
04987562518630Automated Blood Coagulation Analyzer CN-6000SYSMEX CORPORATIONJPA2025-08-22
10812747018531Global Hemostasis - HNHAEMONETICS CORPORATIONJPA2024-04-10
20812747018538Global Hemostasis - HNHAEMONETICS CORPORATIONJPA2024-04-10
00630414639772Standard Human PlasmaSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00630414640563Calcium Chloride SolutionSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00842768018893Standard Human PlasmaSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
00842768018916Calcium Chloride SolutionSiemens Healthcare Diagnostics Products GmbHJPA2024-03-25
04987562518654Automated Blood Coagulation Analyzer CS-5100SYSMEX CORPORATIONJPA2024-02-22
04987562518661Automated Blood Coagulation Analyzer CS-2500SYSMEX CORPORATIONJPA2024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620SYSMEX CORPORATIONJPA2024-02-22
00810149090622R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149091681R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149092619R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149092626R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149092749R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149093258R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149095542R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
00810149096969R&D Batteries, Inc.R & D Batteries, Inc.JPA2024-01-01
G0561009910Tris Buffered SalineBio/Data CorporationJPA2023-08-30