TEG5000 HEMOSTASIS SYSTEM

GUDID 20812747018002

Multiple coagulation factor IVD, reagent

Primary Device ID	20812747018002
NIH Device Record Key	7d49e601-5251-4bbf-ab4b-510525fd4ca5
Commercial Distribution Status	In Commercial Distribution
Brand Name	TEG5000 HEMOSTASIS SYSTEM
Version Model Number	07-004
Company DUNS	057827420
Company Name	HAEMONETICS CORPORATION
Device Count	25
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00812747018008 [Unit of Use]
GS1	20812747018002 [Primary]

JPA	SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Steralize Prior To Use	false
Device Is Sterile	false

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