Foley Catheter

GUDID 10369771001072

Foley Catheter 20fr 5cc

GERI-GENTLE CORPORATION

Indwelling urethral drainage catheter
Primary Device ID10369771001072
NIH Device Record Key98b7147b-f51a-48d6-bb7a-97f522fdcf56
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoley Catheter
Version Model Number21-061
Company DUNS361663839
Company NameGERI-GENTLE CORPORATION
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100369771001075 [Primary]
GS110369771001072 [Package]
Contains: 00369771001075
Package: Inner [10 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 Number2
Public Version Date2019-07-12
Device Publish Date2019-02-26

On-Brand Devices [Foley Catheter]

10369771001133Foley Catheter 16fr 30cc
20369771001123Foley Catheter 24fr 5cc
10369771001119Foley Catheter 24fr 30cc
20369771001093Foley Catheter 22fr 5cc
10369771001089Foley Catheter 22fr 30cc
10369771001072Foley Catheter 20fr 5cc
10369771001065Foley Catheter 20fr 30cc
10369771001058Foley Catheter 18fr 30cc
20369771001048Foley Catheter 18fr 5cc
20369771001031Foley Catheter 16fr 5cc
20369771001017Foley Catheter 14fr 5cc
10369771001003Foley Catheter 14fr 30cc

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