LabChoice Urine Transfer Devices, For Urine Tube, 100 mL, Sterile

Basic Information

• Brand Name: LabChoice Urine Transfer Devices, For Urine Tube, 100 mL, Sterile
• Primary DI: 00840117329454
• Version / Model: 43024
• Company Name: Dynarex Corporation
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 400
• Record Status: Published
• Publish Date: 2025-03-11
• Public Version: 1
• Public Version Date: 2025-03-19
• Public Version Status: New
• Public Device Record Key: fabd0a25-8b22-49ef-9776-40d46090bd92

Device Description

STERILE-EO

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FMH	Container, Specimen, Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58156	Urine transfer IVD, sterile	A sterile plastic adaptor or dedicated transfer device, intended to be used to assist with the aseptic transfer of a urine specimen from the primary collection container to an evacuated urine specimen container for subsequent culture, analysis, and/or other investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810180841504	GS1
Primary	00840117329454	GS1