Balloon G-Tube 7-1810-I

GUDID 00842071136598

18FR Balloon G-Tube with ENFit® Port (Box), MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy tube
Primary Device ID00842071136598
NIH Device Record Keyb6b61a18-feb3-4490-aa10-d62d4b8e2dbe
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalloon G-Tube
Version Model Number7-1810-I
Catalog Number7-1810-I
Company DUNS038101861
Company NameAPPLIED MEDICAL TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net
Phone(440)717-4000
Emailcs@appliedmedical.net

Device Dimensions

Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French
Catheter Gauge18 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071136598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-16
Device Publish Date2024-09-06

On-Brand Devices [Balloon G-Tube]

0084207113663524FR Balloon G-Tube with ENFit® Port (Box), MDR
0084207113662824FR Balloon G-Tube (Box), MDR
0084207113661120FR Balloon G-Tube with ENFit® Port (Box), MDR
0084207113660420FR Balloon G-Tube (Box), MDR
0084207113659818FR Balloon G-Tube with ENFit® Port (Box), MDR
0084207113658118FR Balloon G-Tube (Box), MDR
0084207113657416FR Balloon G-Tube with ENFit® Port (Box), MDR
0084207113656716FR Balloon G-Tube (Box), MDR
0084207113655014FR Balloon G-Tube with ENFit® Port (Box), MDR
0084207113654314FR Balloon G-Tube (Box), MDR
0084207113653612FR Balloon G-Tube with ENFit® Port (Box), MDR
0084207113652912FR Balloon G-Tube (Box), MDR

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