Identity
- Trade Name
- G-Jet® Transgastric-Jejunal Feeding Device FDA UDI
- Generic Name
- Gastrojejunostomy tube FDA UDI
- Device Name
- 16FR x 6.5 cm x 45 cm Low Profile Transgastric-Jejunal Feeding Device FDA UDI
- Model / Reference
- GJ-1665-45 FDA UDI
- Description
- 16FR x 6.5 cm x 45 cm Low Profile Transgastric-Jejunal Feeding Device FDA UDI
Identifiers
- Catalog Number
- GJ-1665-45 FDA UDI
- Primary DI / UDI-DI
- 00842071131340 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Gastrojejunostomy tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 6.5 Centimeter FDA UDICatheter Gauge — 16 French FDA UDILength — 45 Centimeter FDA UDI
Category: Gastrojejunostomy tube
G-Jet® Transgastric-Jejunal Feeding Device by Applied Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrojejunostomy tube.
- EndoVive Jejunal Feeding Tube — Boston Scientific · Class II
- G-Jet® Transgastric-Jejunal Feeding Device — Applied Medical Technology, Inc. · Class II
- G-Jet® Transgastric-Jejunal Feeding Device — Applied Medical Technology, Inc. · Class II
- Traditional G-Jet® — Applied Medical Technology, Inc. · Class II
- Micro G-Jet® — Applied Medical Technology, Inc. · Class II
- G-Jet® Transgastric-Jejunal Feeding Device — Applied Medical Technology, Inc. · Class II
- G-Jet® Transgastric-Jejunal Feeding Device — Applied Medical Technology, Inc. · Class II
- G-Jet® Transgastric-Jejunal Feeding Device — Applied Medical Technology, Inc. · Class II
Cleared under the same submission
K110804 also covers:
- AMT Guidewire — Applied Medical Technology, Inc.
- AMT Guidewire — Applied Medical Technology, Inc.
- AMT Mini Extension Set — Applied Medical Technology, Inc.
- AMT Mini ONE® Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT Mini™ Extension Set — Applied Medical Technology, Inc.
K123716 also covers:
- AMT Guidewire — Applied Medical Technology, Inc.
- AMT Guidewire — Applied Medical Technology, Inc.
- AMT Mini Extension Set — Applied Medical Technology, Inc.
- AMT Mini ONE® Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT MiniONE Extension Set — Applied Medical Technology, Inc.
- AMT Mini™ Extension Set — Applied Medical Technology, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
Sources (1)
- FDA UDI 6ea8896c-d1af-441e-8393-c948be566b94 37 fields · synced Jun 9, 2026