FDA.reportPublic FDA data

Global Hemostasis - HN

Primary DI
20812747018538
Brand
Global Hemostasis - HN
Company
HAEMONETICS CORPORATION
Model
07-604-US
Device description
CITRATED: K, KH, RTH, FFH
Published
2024-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K232018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232018000Citrated: K, KH, RTH, FFHHaemonetics Corporation2024-03-29JPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20812747018538PackageGS110In Commercial Distribution
10812747018531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081274701853820812747018538
1081274701853110812747018531

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor 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 one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
057827420
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10812747018463Hemostasis System07-605-US2021-06-17
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

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
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
G0561009940Sodium CitrateBio/Data CorporationJPA2023-08-30