HAEMONETICS CELL SAVER ELITE+ SYSTEM

Basic Information

• Brand Name: HAEMONETICS CELL SAVER ELITE+ SYSTEM
• Primary DI: 30812747016364
• Version / Model: CSE-EW-US
• Company Name: HAEMONETICS CORPORATION
• Labeler DUNS: 057827420
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-05
• Public Version: 8
• Public Version Date: 2023-10-24
• Public Version Status: Update
• Public Device Record Key: ffb63115-e370-4443-83bb-2f7ec12c7b98

Device Description

CELL SAVER ELITE+

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: MR Unsafe
• 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
CAC	APPARATUS, AUTOTRANSFUSION	Anesthesiology	868.5830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66789	Autotransfusion system blood collection/processing pump	An electrically-powered device intended to be used in conjunction with a collection of appropriate containers and tubing (not included) to produce pressure for the collection of blood from a patient and the subsequent processing (filter/wash) of the blood components (e.g., red or white blood cells, platelets) as part of an autotransfusion procedure. It typically incorporates a peristaltic and aspiration (suction) pump. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30812747016364	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162423	000
K221722	000