HAEMONETICS PCS 300 PLASMA COLLECTION SYSTEM

Basic Information

• Brand Name: HAEMONETICS PCS 300 PLASMA COLLECTION SYSTEM
• Primary DI: 30812747011659
• Version / Model: PCS-300-US
• Company Name: HAEMONETICS CORPORATION
• Labeler DUNS: 057827420
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-01
• Public Version: 6
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 44a7f835-5828-4a6c-a367-fa9f57ad0771

Device Description

PCS 300, US

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: Yes
• 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	30812747011659	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK170045	0
BK180185	0
BK200498	0

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 8 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius