Guardian

Basic Information

• Brand Name: Guardian
• Primary DI: 00860008160300
• Version / Model: GS-TB
• Catalog Number: GS-TB
• Company Name: TURNCARE INC
• Labeler DUNS: 106254663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-07
• Public Version: 1
• Public Version Date: 2024-11-15
• Public Version Status: New
• Public Device Record Key: 87cbd26e-933d-4b4a-93c7-59864da3eb6e

Device Description

Guardian System Tote Bag

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	880.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31072	Personal device holder, single-use	A portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008160300	GS1