i.Series®

Basic Information

• Brand Name: i.Series®
• Primary DI: 00816394021695
• Version / Model: iBX020-GX
• Catalog Number: 5110020
• Company Name: HELMER, INC.
• Labeler DUNS: 086685682
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-06
• Public Version: 1
• Public Version Date: 2023-10-16
• Public Version Status: New
• Public Device Record Key: bafef8ff-0862-438b-902e-33608164cb8b

Device Description

Blood Bank Compartmental Access Refrigerator 20 Bin

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: 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
KSE	Refrigerator, Freezer, Blood Storage	Hematology	864.9700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35486	Blood refrigerator	An electrically-powered device intended to be used to store and/or transport whole blood and blood components (e.g., blood cells, plasma) while keeping them cold (temperatures from 1° to 6° Celsius). It may include handles and/or wheels for transportation, internal shelving for storage and easy location of blood containers (e.g., bags); a corrosion-resistant (typically stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; and sensors, controls, monitors, chart recorders (week-long recordings are typical), and alarms (over temperature, under temperature, and power failure).	No	Active
60607	Blood refrigerator/freezer	An electrically-powered device intended to be used to store and/or transport whole blood and/or blood components (e.g., blood cells, plasma) while keeping them cold (temperatures from 1° to 6° Celsius), or alternatively frozen (-18° to -30° Celsius). It includes refrigeration and freezing compartments with internal shelving, controls, sensors and alarms to signal out-of-range temperatures and power failures; its interior is typically corrosion-resistant (typically stainless steel or synthetic materials) to minimize the risk of adulteration, contamination, and/or corrosion of contents. The refrigeration unit is typically equipped with a safety thermostat to protect the products from freezing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816394021695	GS1