TR1000 with straight armrests

Basic Information

• Brand Name: TR1000 with straight armrests
• Primary DI: 07350016060004
• Version / Model: 0521000
• Company Name: Tr Equipment AB
• Labeler DUNS: 354437485
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-11
• Public Version: 1
• Public Version Date: 2023-12-19
• Public Version Status: New
• Public Device Record Key: 94f944a1-8763-4349-b5cf-a377a38a7d53

Device Description

TR1000 with straight armrests

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
FPO	Stretcher, Wheeled	General Hospital	880.6910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43494	Bathing/changing table, mobile	A raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off) mounted on a foldable frame with legs designed to support a recumbent patient for bathing, showering or changing. It is designed to be placed in an appropriate bathing area or where the patient can be given a body bath (washed by hand by assisting staff). The device is used primarily for a patient with a disability incapable of supporting themself in an upright position for bathing. It is designed to be portable or easily moved on wheels to different locations.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350016060004	GS1