FDA.reportPublic FDA data

Traditional G-Jet®

Primary DI
00842071106362
Brand
Traditional G-Jet®
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
TGJ-14-15-I
Catalog number
TGJ-14-15-I
Device description
14FR x 15 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device (ENFit®)
Published
2023-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182804000Traditional Length GJ Feeding DeviceApplied Medical Technology, Inc.2019-03-01KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071106362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071106362008420711063628420711063620842071106362

GMDN Terms#

Term, Definition table
TermDefinition
Gastrojejunostomy tubeA thin, flexible, hollow tube intended to be percutaneously inserted into the stomach, typically through puncture of the abdominal wall and stomach after distention of the stomach by endoscopic methods, with an extended portion inserted through the pylorus into the jejunum, to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect or a neuromuscular condition) and/or to provide drainage/decompression for an obstructed stomach; it may also be used to administer medication to a patient. Additional invasive devices used to assist gastrostomy and tube introduction (e.g., guidewire) may be included with the tube. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge14French
Length15Centimeter

Contacts#

Phone, Email table
PhoneEmail
(440)717-4000cs@appliedmedical.net

Regulatory Flags#

DUNS number
038101861
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071132163MiniACE Low Profile Antegrade Continence Enema Irrigation SetE2-1221E2-1221, 2-12212024-06-26
00842071132170MiniACE Low Profile Antegrade Continence Enema Irrigation SetE2-1221-ISOSAFE2-1221-ISOSAF, 2-1221-ISOSAF2024-06-26
00842071132187MiniACE Low Profile Antegrade Continence Enema Irrigation SetE2-2421E2-2421, 2-24212024-06-26
00842071132194MiniACE Low Profile Antegrade Continence Enema Irrigation SetE2-2421-ISOSAFE2-2421-ISOSAF, 2-2421-ISOSAF2024-06-26
00842071136642MiniACEACE-1008ACE-10082024-08-30
00842071136659MiniACEACE-1008-IACE-1008-I2024-08-30
00842071136666MiniACEACE-1010ACE-10102024-08-30
00842071136673MiniACEACE-10100ACE-101002024-08-30
00842071136680MiniACEACE-10100-IACE-10100-I2024-08-30
00842071136697MiniACEACE-1010-IACE-1010-I2024-08-30
00842071136703MiniACEACE-1012ACE-10122024-08-30
00842071136710MiniACEACE-1012-IACE-1012-I2024-08-30
00842071136727MiniACEACE-1015ACE-10152024-08-30
00842071136734MiniACEACE-1015-IACE-1015-I2024-08-30
00842071136741MiniACEACE-1017ACE-10172024-08-30
00842071136758MiniACEACE-1017-IACE-1017-I2024-08-30
00842071136765MiniACEACE-1020ACE-10202024-08-30
00842071136772MiniACEACE-1020-IACE-1020-I2024-08-30
00842071136789MiniACEACE-1023ACE-10232024-08-30
00842071136796MiniACEACE-1023-IACE-1023-I2024-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071119973MiniACE™APPLIED MEDICAL TECHNOLOGY, INC.PIF2019-09-06
00842071119973MiniACE™APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-09-06
00842071119980MiniACE™APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-09-06
00842071118549MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118549MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118556MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118556MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118563MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118563MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118570MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118570MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118587MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118587MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118594MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118594MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118600MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118600MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118617MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118617MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118624MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118624MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118631MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118631MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118648MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118648MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118655MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118655MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118662MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2018-07-02
00842071118662MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02
00842071118679MiniACE™ Low Profile Antegrade Continence Enema ButtonAPPLIED MEDICAL TECHNOLOGY, INC.PIF2018-07-02