Disposable Silicone Foley Catheter Two-way 20Fr

GUDID 26938634494859

Guangdong Baihe Medical Technology Co., Ltd.

Indwelling urethral drainage catheter
Primary Device ID26938634494859
NIH Device Record Key37a9e2cc-93c9-441f-aca7-d183ab2f19e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Silicone Foley Catheter Two-way 20Fr
Version Model Number110-FX-022040
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
GS106938634494855 [Primary]
GS116938634494852 [Package]
Contains: 06938634494855
Package: [10 Units]
In Commercial Distribution
GS126938634494859 [Package]
Contains: 16938634494852
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 20Fr]

26938634494859110-FX-022040
26938634494842040-FX-022040

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