FDA.reportPublic FDA data

G-Jet® Transgastric-Jejunal Feeding Device

Primary DI
00842071134303
Brand
G-Jet® Transgastric-Jejunal Feeding Device
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
GJ-1430-45
Catalog number
GJ-1430-45
Device description
14FR x 3.0 cm x 45 cm Low Profile Transgastric-Jejunal Feeding Device, MDR
Published
2025-01-20
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)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110804000
K123716000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110804000AMT G-J TUBEApplied Medical Technology, Inc.2011-10-19KNT
K123716000AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KITApplied Medical Technology, Inc.2013-04-19KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071134303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071134303008420711343038420711343030842071134303

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
Length3Centimeter
Length45Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071146290MINI Balloon Button5-14605-14602026-09-29
00842071146306MINI Balloon Button5-1460-I5-1460-I2026-09-29
00842071146313MINI Balloon Button5-14655-14652026-09-29
00842071146320MINI Balloon Button5-1465-I5-1465-I2026-09-29
00842071146351MINI Balloon Button5-16125-16122026-09-29
00842071146368MINI Balloon Button5-1612-I5-1612-I2026-09-29
00842071146399MINI Balloon Button5-16175-16172026-09-29
00842071146405MINI Balloon Button5-1617-I5-1617-I2026-09-29
00842071146450MINI Balloon Button5-16255-16252026-09-29
00842071146467MINI Balloon Button5-1625-I5-1625-I2026-09-29
00842071146511MINI Balloon Button5-16355-16352026-09-29
00842071146528MINI Balloon Button5-1635-I5-1635-I2026-09-29
00842071146559MINI Balloon Button5-16445-16442026-09-29
00842071146566MINI Balloon Button5-1644-I5-1644-I2026-09-29
00842071146597MINI Balloon Button5-18125-18122026-09-29
00842071146603MINI Balloon Button5-1812-I5-1812-I2026-09-29
00842071146436MINI Balloon Button5-16235-16232026-07-17
00842071146443MINI Balloon Button5-1623-I5-1623-I2026-07-17
00842071153083NutraGlide Nasal Feeding TubeENFT-05055-IENFT-05055-I, NFT-05055-I2026-06-10
00842071153106NutraGlide Nasal Feeding TubeENFT-05090-IENFT-05090-I, NFT-05090-I2026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350770005881CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00350770007915CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00842071146290MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146306MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146313MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146320MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146351MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146368MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146399MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146405MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146450MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146467MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146511MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146528MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146559MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146566MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146597MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146603MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
G461CEGCT40M0EndolumikEndolumik, Inc.KNT2026-08-25
00350770006840CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770009094CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770007557CORFLO* Safety PEG KitAvanos Medical, Inc.KNT2026-08-14
00842071146436MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071146443MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071153083NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153106NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153120NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01