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Accessory Platelet Bag with Integrated Sampler - 70031

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.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 35020583700315

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05020583700314

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 05020583700314

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