i.Series®

Basic Information

• Brand Name: i.Series®
• Primary DI: 00816394020766
• Version / Model: PC2200i
• 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: 3
• Public Version Date: 2018-06-26
• Public Version Status: Update
• Public Device Record Key: b11fdf5c-8b2d-4179-96f4-61b30b312121

Device Description

Platelet Incubator

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
KSH	Chamber, Environmental For The Storage Of Platelet Concentrate	Hematology	864.9575	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62158	Platelet incubator	An electrically-powered device intended to be used to store and/or transport platelet concentrates while keeping them warm (typically from 20° to 24° Celsius). It is a cabinet-like chamber with shelves, and typically includes built-in temperature displays and an alarm triggered by out-of-range temperature variations; some types may in addition have built-in platelet agitators.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816394020766	GS1

Customer Contacts

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