AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike

Basic Information

• Brand Name: AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike
• Primary DI: 00810020440768
• Version / Model: 4R2359
• Catalog Number: 4R2359
• Company Name: Fresenius Kabi AG
• Labeler DUNS: 315654579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-22
• Public Version: 1
• Public Version Date: 2023-05-30
• Public Version Status: New
• Public Device Record Key: b86aa957-8ac9-4bfc-8d5b-369a6e418267

Device Description

For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	864.9245	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47572	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810020440765	GS1	Carton	6	In Commercial Distribution
Primary	00810020440768	GS1

Premarket Submissions

Submission Number	Supplement Number
BK230824	0

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: The storage range for this kit is 0°C (32°F) – 40°C (104°F), however it is recommended to be stored at Room Temperature.