ENFit Transition Adapter ETRN203, TRN203

GUDID 00842071133344

Y-Port-to-Female ENFit Adapter (Pouched), MDR

APPLIED MEDICAL TECHNOLOGY, INC.

ENFit/non-ISO80369-standardized linear connector

• Primary Device ID: 00842071133344
• NIH Device Record Key: 0a5b67e3-b643-4930-83f7-ba2396ecf064
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENFit Transition Adapter
• Version Model Number: ETRN203
• Catalog Number: ETRN203, TRN203
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071133283 [Primary]
GS1	00842071133344 [Package]; Contains: 00842071133283; Package: Box (TRN203) [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-05
• Device Publish Date: 2025-05-28

On-Brand Devices [ENFit Transition Adapter]

• 00842071133351: Rigid Med-Port Y-Port-to-Female ENFit Adapter (Pouched), MDR
• 00842071133344: Y-Port-to-Female ENFit Adapter (Pouched), MDR
• 00842071133337: Female Catheter-to-Female ENFit Adapter (Pouched), MDR
• 00842071133320: Female Luer/Oral-to-Female ENFit Adapter (Pouched), MDR
• 00842071133313: Male ENFit-to-Stepped Male (Christmas Tree) Adapter (Pouched), MDR
• 00842071133306: Male ENFit-to-Male Luer Adapter (Pouched), MDR