Disposable Silicone Foley Catheter Two-way 24Fr

GUDID 26938634494873

Guangdong Baihe Medical Technology Co., Ltd.

Indwelling urethral drainage catheter
Primary Device ID26938634494873
NIH Device Record Key89f90dc4-a3b0-4e09-838a-042c714533a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Silicone Foley Catheter Two-way 24Fr
Version Model Number040-FX-022440
Company DUNS547055364
Company NameGuangdong Baihe Medical Technology Co., Ltd.
Device Count1
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106938634494879 [Primary]
GS116938634494876 [Package]
Contains: 06938634494879
Package: [10 Units]
In Commercial Distribution
GS126938634494873 [Package]
Contains: 16938634494876
Package: [200 Units]
In Commercial Distribution

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 Date2016-09-20

On-Brand Devices [Disposable Silicone Foley Catheter Two-way 24Fr]

26938634494880110-FX-022440
26938634494873040-FX-022440

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.