AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly 4R2353G

GUDID 10810020440161

Apheresis system tubing set

Primary Device ID	10810020440161
NIH Device Record Key	f5a80a37-e92a-448f-85b2-5cfc32d0b095
Commercial Distribution Status	In Commercial Distribution
Brand Name	AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly
Version Model Number	4R2353G
Catalog Number	4R2353G
Company DUNS	315654579
Company Name	Fresenius Kabi AG
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

Special Storage Condition, Specify	Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, Specify	Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, Specify	Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, Specify	Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, Specify	Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, Specify	Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, Specify	Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, Specify	Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, Specify	Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, Specify	Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.
Special Storage Condition, Specify	Between 0 and 0 *Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.

Device Issuing Agency	Device ID
GS1	00810020440164 [Primary]
GS1	10810020440161 [Package] Contains: 00810020440164 Package: Carton [3 Units] In Commercial Distribution

GKT	Separator, Automated, Blood Cell, Diagnostic

Steralize Prior To Use	false
Device Is Sterile	true

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