HAEMONETICS PCS 2 APHERESIS SYSTEM

Basic Information

• Brand Name: HAEMONETICS PCS 2 APHERESIS SYSTEM
• Primary DI: 30812747011833
• Version / Model: 06002-CP-220-EW
• Company Name: HAEMONETICS CORPORATION
• Labeler DUNS: 057827420
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-03
• Public Version: 5
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: de59021f-21ba-4cf7-8c73-0843cc56e59e

Device Description

PCS2, LIST NO, LN06002-CP-220-EW

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
17605	Autotransfusion system blood component processing set	A collection of noninvasive devices that typically includes tubing, containers (e.g., bags or bowls for treatment, reinfusion, waste disposal) and filters intended to be used to process (filter/wash) blood components (e.g., red or white blood cells, platelets) in conjunction with a dedicated pump (not included) as part of an autotransfusion procedure; it is not dedicated to suction and/or anticoagulation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30812747011833	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
BK060033	0