Silicone 3-way Foley Balloon Catheter (Standard Ba

GUDID 04710961932581

FORTUNE MEDICAL INSTRUMENT CORP.

Indwelling urethral drainage catheter Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial
Primary Device ID04710961932581
NIH Device Record Key45f9ea17-bcbb-400b-8863-b01ae792c5ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone 3-way Foley Balloon Catheter (Standard Ba
Version Model Number1830-0526
Company DUNS656763489
Company NameFORTUNE MEDICAL INSTRUMENT CORP.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104710961932581 [Primary]
GS114710961932588 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZLCatheter, Retention Type, Balloon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2018-09-24
Device Publish Date2016-03-11

On-Brand Devices [Silicone 3-way Foley Balloon Catheter (Standard Ba]

047109619325811830-0526
047109619325741830-0524
047109619325671830-0522
047109619325501830-0520
047109619325431830-0518
047109619325361830-0516
047109619325291830-0514

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