i.Series®

Basic Information

• Brand Name: i.Series®
• Primary DI: 00816394021633
• Version / Model: iUF124-GX
• Company Name: HELMER, INC.
• Labeler DUNS: 086685682
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-31
• Public Version: 2
• Public Version Date: 2024-01-24
• Public Version Status: Update
• Public Device Record Key: 1cec6b7b-e165-4a9b-9f26-57f36ab6e9f6
• Distribution End Date: 2019-02-01

Device Description

Ultra-Low Freezer, 24 cu ft Added by mistake

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
KSE	Refrigerator, Freezer, Blood Storage	Hematology	864.9700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35704	Blood plasma freezer	An electrically-powered device intended to be used to store and/or transport blood plasma while keeping it frozen (temperatures of or below -18° Celsius). It typically includes internal shelving for storage and easy location of plasma containers (e.g., bags); a corrosion-resistant (typically stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; forced-air circulation and automatic defrost capability; and sensors, controls, monitors, chart recorders (week-long recordings are typical), and alarms (over temperature, under temperature, and power failure).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816394021633	GS1

Customer Contacts

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