AMT G-Jet® Winged Luer Adapter with Syringe E4-7000, 4-7000

GUDID 00842071111816

Winged Luer with Syringe (Pouched) - For Direct G & J Port Access

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrojejunostomy tube
Primary Device ID00842071111816
NIH Device Record Key9d9beb4b-f945-471e-87c2-b36a61763fc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMT G-Jet® Winged Luer Adapter with Syringe
Version Model NumberE4-7000
Catalog NumberE4-7000, 4-7000
Company DUNS038101861
Company NameAPPLIED MEDICAL TECHNOLOGY, INC.
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 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
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071106904 [Primary]
GS100842071111816 [Package]
Contains: 00842071106904
Package: Box (4-7000) [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2016-09-23

Devices Manufactured by APPLIED MEDICAL TECHNOLOGY, INC.

00842071136376 - AMT Stiffener for Initial Placement2025-08-26 Guidewire Compatible Stiffener for Initial Placement (Pouched), MDR
00842071148966 - AMT Stiffener for Initial Placement2025-08-26 Guidewire Compatible Stiffener for Initial Placement (Longer Length, Pouched), MDR
00842071133214 - AMT Balloon Stoma Measurement Device2025-08-04 Balloon Stoma Measuring Device (Pouched), MDR
00842071145958 - MINI Balloon Button2025-07-15 12FR x 3.5 cm MINI Balloon Button Kit, MDR
00842071145965 - MINI Balloon Button2025-07-15 12FR x 3.5 cm MINI Balloon Button Kit (ENFit), MDR
00842071145811 - MINI Balloon Button2025-06-23 12FR x 1.5 cm MINI Balloon Button Kit, MDR
00842071145828 - MINI Balloon Button2025-06-23 12FR x 1.5 cm MINI Balloon Button Kit (ENFit), MDR
00842071145835 - MINI Balloon Button2025-06-23 12FR x 1.7 cm MINI Balloon Button Kit, MDR

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.