TEG5000 HEMOSTASIS SYSTEM

GUDID 20812747018125

PLATELETMAPPING MULTIPAK AA

HAEMONETICS CORPORATION

Platelet aggregation study IVD, reagent Platelet aggregation study IVD, reagent
Primary Device ID20812747018125
NIH Device Record Key80b5e9fa-4a69-4373-904b-63a8c435534e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEG5000 HEMOSTASIS SYSTEM
Version Model Number07-042
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS120812747018125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOZSYSTEM, AUTOMATED PLATELET AGGREGATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-25

On-Brand Devices [TEG5000 HEMOSTASIS SYSTEM]

20812747018132DISPOSABLE CUPS & PINS, CLEAR
20812747018125PLATELETMAPPING MULTIPAK AA
20812747018118PLATELETMAPPING MULTIPAK ADP
20812747018101PLATELETMAPPING MULTIPAK ADP & AA
20812747018088RAPIDTEG REAGENT
20812747018033LEVEL II CONTROL
20812747018026LEVEL I CONTROL
20812747018019DISPOSABLE CUPS & PINS HEPARINASE
20812747018002KAOLIN

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