iFIX

Basic Information

• Brand Name: iFIX
• Primary DI: 29010279000170
• Version / Model: Head Mask XL
• Catalog Number: 29341
• Company Name: iSYS Medizintechnik GmbH
• Labeler DUNS: 300207996
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-03-31
• Public Version: 2
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: 93a136a4-cc61-426e-b5e5-1952b0860c4e

Device Description

short-term patient stabilization device

Device Characteristics

• Single Use: Yes
• 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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMQ	Restraint, Protective	General Hospital	880.6760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44851	Limb/torso/head restraint, single-use	A non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	29010279000170	GS1
Unit of Use	09010279000176	GS1

Device Sizes

Type	Value	Unit	Text
Length	325	Millimeter