Coag-Sense PT/INR Professional System 03P70-02

GUDID 00861900000374

Prothrombin time (PT) IVD, kit, clotting, rapid

Primary Device ID	00861900000374
NIH Device Record Key	628437ac-b775-4aee-a32e-ca68d0c42598
Commercial Distribution Status	In Commercial Distribution
Brand Name	Coag-Sense PT/INR Professional System
Version Model Number	200222
Catalog Number	03P70-02
Company DUNS	007943352
Company Name	COAGUSENSE INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
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 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
Storage Environment Temperature	Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
Storage Environment Temperature	Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
Storage Environment Temperature	Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
Storage Environment Temperature	Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
Storage Environment Temperature	Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
Storage Environment Temperature	Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
Storage Environment Temperature	Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
Storage Environment Temperature	Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
Storage Environment Temperature	Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
Storage Environment Temperature	Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit
Storage Environment Temperature	Between 35 Degrees Fahrenheit and 72 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	00861900000374 [Primary]

GJS	Test, Time, Prothrombin

Steralize Prior To Use	false
Device Is Sterile	false

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