Extension Tube

Basic Information

• Brand Name: Extension Tube
• Primary DI: 07290109270029
• Version / Model: B
• Catalog Number: FPR00001
• Company Name: TILLA CARE LTD
• Labeler DUNS: 600502332
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-31
• Public Version: 1
• Public Version Date: 2020-01-08
• Public Version Status: New
• Public Device Record Key: b1d1c44a-747e-4b2e-9315-6e4af4853d4b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58157	Urine transfer IVD, non-sterile	A non-sterile plastic adaptor or dedicated transfer device, intended to be used to assist with the transfer of a urine specimen from the primary collection container to an evacuated urine specimen container for subsequent 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
Primary	07290109270029	GS1