CONTROL 550-13 CLOTTRAC HR 11L 30PK Medical Device Identification

GUDID 20613994130383

Multiple coagulation factor IVD, control

Primary Device ID	20613994130383
NIH Device Record Key	5837fa14-dcdf-471f-ac4e-ec3bfef66aa2
Commercial Distribution Status	In Commercial Distribution
Version Model Number	550-13
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	30
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	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Storage Environment Temperature	Between 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Upon receipt, the control should be stored refrigerated, from 2° to 10°C, until use. Once reconstituted, the control is stable for 2 hours at room temperature, 15° to 25°C.
Storage Environment Temperature	Between 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Upon receipt, the control should be stored refrigerated, from 2° to 10°C, until use. Once reconstituted, the control is stable for 2 hours at room temperature, 15° to 25°C.

Device Issuing Agency	Device ID
GS1	00613994130389 [Unit of Use]
GS1	20613994130383 [Primary]

JPA	SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Steralize Prior To Use	false
Device Is Sterile	false