TUBING SYSTEM FOR PLASMAPHERESIS

GUDID 18855036012850

Apheresis system tubing set

Primary Device ID	18855036012850
NIH Device Record Key	8fe266be-b16b-4db2-a760-0743ee0376e3
Commercial Distribution Status	In Commercial Distribution
Brand Name	TUBING SYSTEM FOR PLASMAPHERESIS
Version Model Number	NK-M3R(U)
Company DUNS	136605362
Company Name	KANEKA PHARMA AMERICA LLC
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	true
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 *In transporting and storing the disposable, handle with care and store in a clean and secure area, avoiding exposure to direct sunlight, high humidity or excessive vibration.
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *In transporting and storing the disposable, handle with care and store in a clean and secure area, avoiding exposure to direct sunlight, high humidity or excessive vibration.
Storage Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
GS1	18855036012850 [Primary]
GS1	28855036012857 [Package] Package: Outer Box [6 Units] In Commercial Distribution

PBN	Apheresis For Focal Glomerulosclerosis In Pediatric Patients

Steralize Prior To Use	false
Device Is Sterile	true

18855036020688	Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable de
18855036012850	Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable de