Traditional G-Jet® TGJ-14-22

GUDID 00842071125189

14FR x 22 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube Gastrojejunostomy tube

• Primary Device ID: 00842071125189
• NIH Device Record Key: 82c56df8-faf8-4975-9c9f-734ca100933c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Traditional G-Jet®
• Version Model Number: TGJ-14-22
• Catalog Number: TGJ-14-22
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net

Device Dimensions

• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter
• Catheter Gauge: 14 French
• Length: 22 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071125189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182804

FDA Product Code

• PIF: Gastrointestinal Tubes With Enteral Specific Connectors

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-16
• Device Publish Date: 2019-12-06

On-Brand Devices [Traditional G-Jet® ]

• 00842071125516: 18FR x 45 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device (ENFit®)
• 00842071125493: 18FR x 30 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device (ENFit®)
• 00842071125486: 18FR x 22 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device (ENFit®)
• 00842071125462: 16FR x 45 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device (ENFit®)
• 00842071125448: 16FR x 30 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device (ENFit®)
• 00842071125431: 16FR x 22 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device (ENFit®)
• 00842071125424: 16FR x 15 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device (ENFit®)
• 00842071125417: 14FR x 45 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device (ENFit®)
• 00842071125394: 14FR x 30 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device (ENFit®)
• 00842071125387: 14FR x 22 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device (ENFit®)
• 00842071125370: 14FR x 15 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device (ENFit®)
• 00842071125318: 18FR x 45 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device
• 00842071125295: 18FR x 30 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device
• 00842071125288: 18FR x 22 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device
• 00842071125264: 16FR x 45 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device
• 00842071125240: 16FR x 30 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device
• 00842071125233: 16FR x 22 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device
• 00842071125226: 16FR x 15 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device
• 00842071125219: 14FR x 45 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device
• 00842071125196: 14FR x 30 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device
• 00842071125189: 14FR x 22 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device
• 00842071125172: 14FR x 15 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device
• 00842071125363: 22FR x 45 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device
• 00842071125349: 22FR x 30 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device