TruAdvance®

GUDID 50850045818482

Indwelling urethral catheterization kit, adult

Primary Device ID	50850045818482
NIH Device Record Key	f92ac932-c646-4b2f-9a1c-af7951ba9fd2
Commercial Distribution Status	In Commercial Distribution
Brand Name	TruAdvance®
Version Model Number	FTDS18UM
Company DUNS	828918164
Company Name	HR PHARMACEUTICALS INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00850045818487 [Primary]
GS1	50850045818482 [Package] Contains: 00850045818487 Package: Case [10 Units] In Commercial Distribution

OHR	Catheter Care Tray

Steralize Prior To Use	false
Device Is Sterile	true

50850045818482	TruAdvance® 100% Silicone Dual-Balloon Foley Catheter Tray with Urine Meter
50850045818475	TruAdvance® 100% Silicone Dual-Balloon Foley Catheter Tray with Urine Meter
50850045818468	TruAdvance® 100% Silicone Dual-Balloon Foley Catheter Tray with Urine Meter

Mark Image Registration \| Serial	Company Trademark Application Date
TRUADVANCE 98975083 not registered Live/Pending	Wiesman Holdings, LLC 2023-05-25
TRUADVANCE 98014239 not registered Live/Pending	Wiesman Holdings, LLC 2023-05-25