Balloon G-Tube 7-1610

GUDID 00842071136567

16FR Balloon G-Tube (Box), MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy tube
Primary Device ID00842071136567
NIH Device Record Key426d5408-2d06-4b89-b8c3-4c3055fafb77
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalloon G-Tube
Version Model Number7-1610
Catalog Number7-1610
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 Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French
Catheter Gauge16 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071136567 [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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