Traditional G-Jet® TGJ-18-45

GUDID 00842071125318

18FR x 45 cm - AMT Traditional G-Jet® Transgastric-Jejunal Feeding Device

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrojejunostomy tube

• Primary Device ID: 00842071125318
• NIH Device Record Key: b71d41de-7743-4bc8-8238-6705c58a518b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Traditional G-Jet®
• Version Model Number: TGJ-18-45
• Catalog Number: TGJ-18-45
• 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

• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French
• Length: 45 Centimeter
• Catheter Gauge: 18 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071125318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182804

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

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