Trulife

Basic Information

• Brand Name: Trulife
• Primary DI: 00645517399300
• Version / Model: A37-KIT-NIH
• Company Name: TRULIFE LIMITED
• Labeler DUNS: 289728891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-31
• Public Version: 2
• Public Version Date: 2023-06-07
• Public Version Status: Update
• Public Device Record Key: cb33e45d-e2a4-4467-b6e6-df0909351fd9

Device Description

KIT PAD/STRAP NON-INVASIVE HALO

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Lot/Batch Number: Yes
• 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
MRI	ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45258	Head/neck immobilizer, reusable	A rigid or non-rigid device, usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00645517399300	GS1