AMT Y-Port Accessory E4-0005, 4-0005

GUDID 00842071113636

Single ENFit Y-Port Accessory (Single Female Enfit to Male Enfit and Bolus Port)

APPLIED MEDICAL TECHNOLOGY, INC.

Enteral feeding kit, adult/paediatric, sterile

• Primary Device ID: 00842071113636
• NIH Device Record Key: 4c6f14b5-e0c8-4ca2-8f41-66e1d5329ac7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Y-Port Accessory
• Version Model Number: E4-0005
• Catalog Number: E4-0005, 4-0005
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071113612 [Primary]
GS1	00842071113636 [Package]; Contains: 00842071113612; Package: Box (4-0005) [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142989

FDA Product Code

• PIF: Gastrointestinal Tubes With Enteral Specific 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: 2016-09-23

On-Brand Devices [AMT Y-Port Accessory]

• 00842071113643: Dual ENFit Y-Port Accessory (Single Female Enfit to Dual Male Enfit)
• 00842071113636: Single ENFit Y-Port Accessory (Single Female Enfit to Male Enfit and Bolus Port)