elabeling.terumobct.com
Rika Plasma Bottle - 21300
Device Description
A collection of sterile and disposable/consumable devices intended to be used to prepare for and perform (connect the patient) an apheresis treatment (e.g., immunoadsorption, plasmapheresis, plasma exchange) with an apheresis system. It typically consists of tubing, separation devices (e.g., adsorber, filter), and rinsing solutions for preparation of the extracorporeal circuit. This is a single-use device.
Environmental Conditions
- Keep Dry (box level)
- Protect from Sun (bottle level)
- Fragile (box level)
- 30.00
- 0.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GKT
Device Name: Separator, Automated, Blood Cell, Diagnostic
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.9245
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 35020583213006
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05020583213005
Package Quantity: 12
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 05020583213005
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A