Home GUDID 10868465000112 Plasma Exchange Tubeset
Primary DI 10868465000112
Brand Plasma Exchange Tubeset
Company ASAHI KASEI MEDICAL AMERICA INC.
Model 066I
Catalog number 066I
Published 2015-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10868465000112 Package GS1 6 In Commercial Distribution 00868465000115 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10868465000112 10868465000112 00868465000115 00868465000115 868465000115 0868465000115
GMDN Terms# Term, Definition table Term Definition Apheresis system tubing set A collection of sterile, flexible, plastic tube segments and associated items (e.g., connectors, line clamp, drip chamber) intended to be used in an apheresis system to channel blood from the patient to an appropriate apheresis column before being returned to the patient. It creates a closed-circuit for the extracorporeal removal of a constituent of whole blood (e.g., leukocytes, plasma). The channeling of apheresis solutions for the priming, regeneration, preservation of columns before or after an apheresis procedure may also be through the tubing set. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 32 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 828593785 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00868465000108 Plasma Exchange tubeset 064I 064I 2015-09-23 00868465000115 Plasma Exchange Tubeset 066I 066I 2015-09-23 10868465000105 Plasma Exchange tubeset 064I 064I 2015-09-23
Other Devices Sharing Product Codes# 
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