TEG HEMOSTASIS SYSTEM

GUDID 10812747018043

CALCIUM CHLORIDE, 0.2M, 5 ML

HAEMONETICS CORPORATION

Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD
Primary Device ID10812747018043
NIH Device Record Keya6958339-a5ae-45c1-87a1-b6af9fcba261
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEG HEMOSTASIS SYSTEM
Version Model Number07-012
Company DUNS057827420
Company NameHAEMONETICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com
Phone+1(800)-537-2802
Emailpirdesk@Haemonetics.com

Device Dimensions

Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS110812747018043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-10-10
Device Publish Date2017-07-31

Devices Manufactured by HAEMONETICS CORPORATION

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30812747013516 - MCS+ (LN8150) RBC APHERESIS2023-10-19 2 UNIT RED CELL SET W/RC2H FIL
30812747015008 - HAEMONETICS ACP 215 SYSTEM2023-10-19 RBC GLYCEROLIZATION SET
30812747015015 - HAEMONETICS ACP 215 SYSTEM2023-10-19 RBC DE-GLYCEROL./CELL WASH SET
30812747015022 - HAEMONETICS ACP 215 SYSTEM2023-10-19 RBC DE-GLYCEROL. SET 325ML BMB
10812747018043 - TEG HEMOSTASIS SYSTEM2023-10-10CALCIUM CHLORIDE, 0.2M, 5 ML
10812747018043 - TEG HEMOSTASIS SYSTEM2023-10-10 CALCIUM CHLORIDE, 0.2M, 5 ML
30812747019334 - Haemonetics® NexSys PCS® System2023-07-07 0625Q-00 Plasma Bowl
30812747012861 - MCS 90002023-02-15

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