Biotronix Healthcare Foley Trays UR1416FT

GUDID 10864085000495

Indwelling urethral catheterization kit

Primary Device ID	10864085000495
NIH Device Record Key	451e1527-bbed-4ede-a7bc-158419d86f03
Commercial Distribution Status	In Commercial Distribution
Brand Name	Biotronix Healthcare Foley Trays
Version Model Number	UR1416FT
Catalog Number	UR1416FT
Company DUNS	065762392
Company Name	BIOTRONIX HEALTHCARE INDUSTRIES, 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	00864085000498 [Primary]
GS1	10864085000495 [Package] Contains: 00864085000498 Package: Case [10 Units] In Commercial Distribution

OHR	Catheter Care Tray

Steralize Prior To Use	false
Device Is Sterile	true

10864085000495	Pre-Connected Latex Foley Tray 16FR
10850005165009	Pre-Connected Latex Foley Tray 18FR