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G-Jet® Transgastric-Jejunal Feeding Device

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref GJ-1640-45

by Applied Medical Technology, Inc.

Identity

Trade Name
AMT G-JET® - Low-Profile Transgastric-Jejunal Feeding Device EUDAMED
G-Jet® Transgastric-Jejunal Feeding Device FDA UDI
Generic Name
Gastrojejunostomy tube FDA UDI
Device Name
AMT G-JET® EUDAMED
16FR x 4.0 cm x 45 cm Low Profile Transgastric-Jejunal Feeding Device, MDR FDA UDI
Model / Reference
GJ-1640-45 EUDAMEDFDA UDI
Description
16FR x 4.0 cm x 45 cm Low Profile Transgastric-Jejunal Feeding Device, MDR FDA UDI

Identifiers

Catalog Number
GJ-1640-45 FDA UDI
Primary DI / UDI-DI
00842071134969 EUDAMEDFDA UDI
Basic UDI-DI
08420711LOWPROFILEGJETLH EUDAMED
510(k) Number
K110804 FDA UDI
K123716 FDA UDI
FDA Product Code
KNT FDA UDI
EMDN Code
G020299 GASTROINTESTINAL FEEDING/ASPIRATION TUBES - OTHER EUDAMED
GMDN Term
Gastrojejunostomy tube FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Market of Registration
Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 45 Centimeter FDA UDI
Catheter Gauge — 16 French FDA UDI
Length — 4.0 Centimeter FDA UDI

Category: Gastrojejunostomy tube

G-Jet® Transgastric-Jejunal Feeding Device by Applied Medical Technology, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Gastrojejunostomy tube.

Cleared under the same submission

K110804 also covers:

K123716 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Applied Medical Technology, Inc.

Sources (2)

  • FDA UDI 660927df-2766-46ab-9c43-761694fb0e7f 37 fields · synced Oct 6, 2026
  • EUDAMED 56478da7-76c9-4d3d-8973-dfa3975ce404 61 fields · synced Sep 30, 2026