i.Series®

Basic Information

• Brand Name: i.Series®
• Primary DI: 00816394020810
• Version / Model: PF96i
• Company Name: HELMER, INC.
• Labeler DUNS: 086685682
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 850cc39d-0b6f-4029-9ba5-c4d90ca84087

Device Description

Platelet Agitator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
KSQ	Device, Blood Mixing And Blood Weighing	Hematology	864.9195	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45226	Platelet agitator	A mains electricity (AC-powered), electromechanical device typically used by blood bank and transfusion services to provide gentle agitation (e.g., side-to-side motion) required for platelet storage. The device will typically provide several drawers on which to place containers of platelets. It may include an audible alarm that sounds if agitation does not occur during use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816394020810	GS1

Customer Contacts

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