CONTROL 306-05POR PORC HMS ORANGE 10BX Medical Device Identification

GUDID 20613994923329

Coagulation timer IVD

Primary Device ID	20613994923329
NIH Device Record Key	0191ac89-b683-4be0-a625-f47f4f080f2d
Commercial Distribution Status	In Commercial Distribution
Version Model Number	306-05POR
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	10
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

Special Storage Condition, Specify	Between 0 and 0 *Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C).
Storage Environment Temperature	Between 2 Degrees Celsius and 10 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C).
Storage Environment Temperature	Between 2 Degrees Celsius and 10 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00613994923325 [Unit of Use]
GS1	20613994923329 [Primary]

JOX	ANALYZER, HEPARIN, AUTOMATED

Steralize Prior To Use	false
Device Is Sterile	false