H.E.L.P.®

Basic Information

• Brand Name: H.E.L.P.®
• Primary DI: 04046964695865
• Version / Model: 7211094
• Catalog Number: 7211094
• Company Name: B.Braun Avitum AG
• Labeler DUNS: 343689704
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2016-03-09
• Public Version: 5
• Public Version Date: 2023-12-01
• Public Version Status: Update
• Public Device Record Key: 57eea4d2-5a7f-4848-b173-1b8f66edb9a6
• Distribution End Date: 2020-11-02

Device Description

HELP HOT FUTURA SET

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMY	LIPOPROTEIN, LOW DENSITY, REMOVAL	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58091	Apheresis kit	A collection of sterile and disposable/consumable devices intended to be used to prepare for and perform (connect the patient) an apheresis treatment (e.g., immunoadsorption, plasmapheresis, plasma exchange) with an apheresis system. It typically consists of tubing, separation devices (e.g., adsorber, filter), and rinsing solutions for preparation of the extracorporeal circuit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964695865	GS1
Unit of Use	04046964695858	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 30 Degrees Celsius