Silicone 2-way Foley Balloon Catheter (Standard Ba

GUDID 04710961931874

Indwelling urethral drainage catheter

Primary Device ID	04710961931874
NIH Device Record Key	4f567a94-67f9-452c-b409-ea6b979a3646
Commercial Distribution Status	In Commercial Distribution
Brand Name	Silicone 2-way Foley Balloon Catheter (Standard Ba
Version Model Number	1822-0512
Company DUNS	656763489
Company Name	FORTUNE MEDICAL INSTRUMENT CORP.
Device Count	10
DM Exempt	false
Pre-market Exempt	false
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	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	04710961931874 [Primary]
GS1	14710961931871 [Unit of Use]

EZL	Catheter, Retention Type, Balloon

Steralize Prior To Use	false
Device Is Sterile	true