FDA.reportPublic FDA data

TEG6s HEMOSTASIS SYSTEM

Primary DI
30812747018351
Brand
TEG6s HEMOSTASIS SYSTEM
Company
HAEMONETICS CORPORATION
Model
07-690-US
Device description
TEG 6S UNIT PACK
Published
2017-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOZSYSTEM, AUTOMATED PLATELET AGGREGATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOZSystem, Automated Platelet AggregationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140893000CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAYCoramed Technologies, LLC2015-01-03JOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30812747018351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081274701835130812747018351

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation analyser IVD, laboratory, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
057827420
Device count
1
Serial number
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04589448510099PL Chip Reservoir SetZACROS CORPORATIONJOZ2024-12-12
04589448510105BAPA tubeZACROS CORPORATIONJOZ2024-12-12
04589448510037PL Chip for T-TAS 01ZACROS CORPORATIONJOZ2024-12-12
04589448510044PL Chip Reservoir Set for T-TAS 01ZACROS CORPORATIONJOZ2024-12-12
04589448510051BAPA tube for T-TAS 01ZACROS CORPORATIONJOZ2024-12-12
14589448510089PL ChipZACROS CORPORATIONJOZ2024-12-12
14589448510096PL Chip Reservoir SetZACROS CORPORATIONJOZ2024-12-12
14589448510102BAPA tubeZACROS CORPORATIONJOZ2024-12-12
04589448510013T-TAS 01 Total Thrombus Formation Analysis SystemZACROS CORPORATIONJOZ2024-12-06
G0561076501AGG/PAK 5 Combo KitBio/Data CorporationJOZ2024-10-01
00811476011045CHRONO-LOGCHRONO-LOG CORPJOZ2023-06-21
00811476011670CHRONO-LOGCHRONO-LOG CORPJOZ2023-06-21
G0561009700AggRecetin Bio/Data CorporationJOZ2022-03-23
G0561012410AggRecetin Bio/Data CorporationJOZ2022-03-23
G0561012971Arachidonic AcidBio/Data CorporationJOZ2022-03-23
G0561013101PAR/PAK IIBio/Data CorporationJOZ2022-03-23
G0561013111EpinephrineBio/Data CorporationJOZ2022-03-23
G0561013121ADPBio/Data CorporationJOZ2022-03-23
G0561015621CollagenBio/Data CorporationJOZ2022-03-23
G0561015801BETA/PakBio/Data CorporationJOZ2022-03-23
10711234500095VerifyNow SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.JOZ2021-04-06
00856893004027AggreguideAGGREDYNE, INC.JOZ2019-09-23
00856893004010AggreDYNE AA AssayAGGREDYNE, INC.JOZ2019-01-01
00856893004065AggreguideAGGREDYNE, INC.JOZ2019-01-01
20856893004014AggreDYNE AA AssayAGGREDYNE, INC.JOZ2019-01-01
00856893004041AggreguideAGGREDYNE, INC.JOZ2019-01-01
10812747018302TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATIONJOZ2017-08-18
10812747018296TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATIONJOZ2017-07-17
10812747018340TEG6S HEMOSTASIS SYSTEMHAEMONETICS CORPORATIONJOZ2017-07-17