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Rika Plasma Separation Set - 21200

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

Handling Environment Temperature - Degrees Celsius

30.00
0.00

Special Storage Condition, Specify

Keep Dry (box and set level)

Special Storage Condition, Specify

Protect from Sun (set level)

Special Storage Condition, Specify

Fragile (box level)

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 Identifiers

Device Id: 35020583212009

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05020583212008

Package Quantity: 34

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 05020583212008

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

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