Foley Catheter

GUDID 10369771001003

Indwelling urethral drainage catheter

Primary Device ID	10369771001003
NIH Device Record Key	acf59211-25fb-4d5e-b0a7-32d4a8e86a54
Commercial Distribution Status	In Commercial Distribution
Brand Name	Foley Catheter
Version Model Number	21-080
Company DUNS	361663839
Company Name	GERI-GENTLE CORPORATION
Device Count	1
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	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00369771001006 [Primary]
GS1	10369771001003 [Package] Contains: 00369771001006 Package: Inner [10 Units] In Commercial Distribution

EZL	Catheter, Retention Type, Balloon

Steralize Prior To Use	false
Device Is Sterile	true