Y-Port Feeding Adapter E4-2015, 4-2015

GUDID 00842071131609

15 FR Y-Port Replacement (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

ENFit/non-ISO80369-standardized linear connector

• Primary Device ID: 00842071131609
• NIH Device Record Key: 45096803-02ae-4f9d-91ca-0cfbd33c7491
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Y-Port Feeding Adapter
• Version Model Number: E4-2015
• Catalog Number: E4-2015, 4-2015
• 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
• 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: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French
• Catheter Gauge: 15 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071131609 [Package]; Contains: 00842071131708; Package: Box (4-2015) [10 Units]; In Commercial Distribution
GS1	00842071131708 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043027

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

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: 2023-07-13
• Device Publish Date: 2023-07-05

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• 00842071114862: 20 FR Y-Port Replacement (Hybrid, Pouched)
• 00842071114855: 15 FR Y-Port Replacement (ISOSAF, Pouched)
• 00842071114848: 15 FR Y-Port Replacement (Hybrid, Pouched)
• 00842071114831: 14FR Y-Port Replacement (Hybrid, Pouched)
• 00842071114824: 12FR Y-Port Replacement (Hybrid, Pouched)
• 00842071106799: 24 FR Y-Port Replacement (Pouched)
• 00842071106782: 20 FR Y-Port Replacement (Pouched)
• 00842071106768: 15 FR Y-Port Replacement (Pouched)
• 00842071106744: 14FR Y-Port Replacement (Pouched)
• 00842071106720: 12FR Y-Port Replacement (Pouched)
• 00842071106713: 20 FR Y-Port Replacement (ISOSAF, Pouched)
• 00842071106706: 14 FR Y-Port Replacement (ISOSAF, Pouched)
• 00842071106690: 12 FR Y-Port Feeding Adapter (ISO SAF - Pouched)
• 00842071131654: 24 FR Y-Port Replacement (ISOSAF, Pouched)
• 00842071131647: 24 FR Y-Port Replacement (Pouched)
• 00842071131630: 20 FR Y-Port Replacement (ISOSAF, Pouched)
• 00842071131623: 20 FR Y-Port Replacement (Pouched)
• 00842071131616: 15 FR Y-Port Replacement (ISOSAF, Pouched)
• 00842071131609: 15 FR Y-Port Replacement (Pouched)
• 00842071131593: 14 FR Y-Port Replacement (ISOSAF, Pouched)
• 00842071131586: 14FR Y-Port Replacement (Pouched)
• 00842071131579: 12 FR Y-Port Feeding Adapter (ISO SAF - Pouched)
• 00842071131562: 12FR Y-Port Replacement (Pouched)
• 00842071133559: 24 FR Feeding Adapter (ENFit, Pouched), MDR
• 00842071133542: 24 FR Y-Port Replacement (Pouched), MDR
• 00842071133535: 20 FR Feeding Adapter (ENFit, Pouched), MDR
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• 00842071133511: 15 FR Feeding Adapter (ENFit, Pouched), MDR
• 00842071133504: 15 FR Y-Port Replacement (Pouched), MDR
• 00842071133498: 14 FR Feeding Adapter (ENFit, Pouched), MDR
• 00842071133481: 14FR Y-Port Replacement (Pouched), MDR
• 00842071133474: 12 FR Feeding Adapter (ENFit, Pouched), MDR
• 00842071133467: 12FR Y-Port Replacement (Pouched), MDR