All Silicone Foley Catheter with Temperature Sensor

GUDID 16944932785950

Temperature-monitoring indwelling urethral drainage catheter

Primary Device ID	16944932785950
NIH Device Record Key	58a1b8e8-ecc6-48d5-b352-6cdabbc2117d
Commercial Distribution Status	In Commercial Distribution
Brand Name	All Silicone Foley Catheter with Temperature Sensor
Version Model Number	F01C012210
Company DUNS	544811862
Company Name	Well Lead Medical Co.,Ltd
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
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	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	06944932785953 [Primary]
GS1	16944932785950 [Package] Contains: 06944932785953 Package: Box [10 Units] In Commercial Distribution
GS1	26944932785957 [Package] Package: Carton [20 Units] In Commercial Distribution

EZL	Catheter, Retention Type, Balloon

Steralize Prior To Use	false
Device Is Sterile	true