Pump Tubing Infusion Line with SmartSense Tag

Basic Information

• Brand Name: Pump Tubing Infusion Line with SmartSense Tag
• Primary DI: 00627825012577
• Version / Model: TUB500-RFID
• Company Name: Laborie Medical Technologies Canada ULC
• Labeler DUNS: 203383526
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-04
• Public Version: 1
• Public Version Date: 2019-10-14
• Public Version Status: New
• Public Device Record Key: f0afabc3-bc05-40fd-808b-96e8c5a1fe1e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	876.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44675	Urological pressure monitoring tubing set	A collection of devices that includes the tubing and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used as an external connection for the invasive measurement of urethral and related urological pressures. This set will interface, either directly or from an intermediate stopcock, between the applied invasive catheter and the measuring transducer. It will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10627825012574	GS1		25	In Commercial Distribution
Primary	00627825012577	GS1