AMT Enfit® Transition Adapter ETRN101, TRN101

GUDID 00842071109059

Male Enfit®-to-Male Luer Adapter (pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Enteral feeding/medication connector, non-sterile ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector ENFit/Luer linear connector

• Primary Device ID: 00842071109059
• NIH Device Record Key: 2e1c928f-a40d-4d7c-8e10-2a45fb1f161d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Enfit® Transition Adapter
• Version Model Number: ETRN101
• Catalog Number: ETRN101, TRN101
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071107994 [Primary]
GS1	00842071109059 [Package]; Contains: 00842071107994; Package: Box (TRN101) [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150034

FDA Product Code

• PIO: Enteral Specific Transition Connectors

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [AMT Enfit® Transition Adapter]

• 00842071109110: Rigid Med-Port Y-Port-to-Female Enfit® Adapter (Pouched)
• 00842071109097: Y-Port-to-Female Enfit® Adapter (Pouched)
• 00842071109080: Female Catheter-to-Female Enfit® Adapter (Pouched)
• 00842071109073: Female Luer/Oral-to-Female Enfit® Adapter (Pouched)
• 00842071109066: Male Enfit®-to-Stepped Male (Christmas Tree) Adapter (Pouched)
• 00842071109059: Male Enfit®-to-Male Luer Adapter (pouched)