AMT Mini™ Extension Set ES6-1226-ISOSAF, S6-1226-ISOSAF

GUDID 00842071109141

12" Right Angle Feeding Set with ENFit ® and Cap (Sterile, Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Enteral tube extension, non-sterile

• Primary Device ID: 00842071109141
• NIH Device Record Key: b95f87cb-2381-47b6-9a24-5a437a51240b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Mini™ Extension Set
• Version Model Number: ES6-1226-ISOSAF
• Catalog Number: ES6-1226-ISOSAF, S6-1226-ISOSAF
• 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
• 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

• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071107901 [Primary]
GS1	00842071109141 [Package]; Contains: 00842071107901; Package: Box (S6-1226-ISOSAF) [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110804

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: 2022-04-04
• Device Publish Date: 2022-03-25

On-Brand Devices [AMT Mini™ Extension Set]

• 00842071114923: 12" Mini Feedset with Right Angle Adapter and Y-Port (Hybrid, pouched)
• 00842071108410: 24" Right Angle Feeding Set with Luer Lock (Pouched)
• 00842071108366: 24" Right Angle Feeding Set with Y-Port (Pouched)
• 00842071108359: 24" Right Angle Feeding Set with ENFit ® and Cap (Pouched)
• 00842071108342: 24" Right Angle Feeding Set with Single Port (Pouched)
• 00842071108335: 24" Bolus Feeding Set with ENFit ® and Cap (Pouched)
• 00842071108328: 24" Bolus Feeding Set with Single Port (Pouched)
• 00842071108236: 12" Right Angle Feeding Set with Luer Lock (Pouched)
• 00842071108182: 12" Right Angle Feeding Set with Y-Port (Pouched)
• 00842071108175: 12" Right Angle Feeding Set with ENFit ® and Cap (Pouched)
• 00842071108168: 12" Right Angle Feeding Set with Single Port (Pouched)
• 00842071108137: 12" Bolus Feeding Set with Y-Port (Pouched)
• 00842071108120: 12" Bolus Feeding Set with ENFit ® and Cap (Pouched)
• 00842071108113: 12" Bolus Feeding Set with Single Port (Pouched)
• 00842071106980: 2" Medication Set with Y-Port (Pouched)
• 00842071108076: 2" Medication Set with ENFit ® and Cap (Pouched)
• 00842071108069: 2" Medication Set with Single Port (Pouched)
• 00842071108465: 24" Right Angle Feeding Set with ENFit ® [ENFit/Medication Port with Cap] (Pouched)
• 00842071108441: 24" Right Angle Feeding Set with ENFit ® (Pouched)
• 00842071108427: 24" Right Angle Locking Feeding Set with ENFit ® (Pouched)
• 00842071108397: 24" Right Angle Feeding Set with Dual ENFit ® Y-Port (Pouched)
• 00842071108373: 24" Right Angle Locking Feeding Set with Dual ENFit ® Y-Port (Pouched)
• 00842071108304: 12" Right Angle Feeding Set with ENFit ® and Cap (Pouched)
• 00842071108281: 12" Right Angle Feeding Set with ENFit ® [ENFit/Medication Port with Cap] (Pouched)
• 00842071108267: 12" Right Angle Feeding Set with ENFit ® (Pouched)
• 00842071108243: 12" Right Angle Locking Feeding Set with ENFit ® (Pouched)
• 00842071108212: 12" Right Angle Feeding Set with Dual ENFit ® Y-Port (Pouched)
• 00842071108199: 12" Right Angle Locking Feeding Set with Dual ENFit ® Y-Port (Pouched)
• 00842071108144: 12" Bolus Feeding Set with Dual ENFit ® Y-Port (Pouched)
• 00842071108090: 2" Medication Set with Dual ENFit ® Y-Port (Pouched)
• 00842071129163: 12" Right Angle Non-PVC Feeding Set with Dual ENFit ® Y-Port (Pouched)
• 00842071109141: 12" Right Angle Feeding Set with ENFit ® and Cap (Sterile, Pouched)
• 00842071109127: 2" Medication Set with Dual ENFit ® Y-Port (Sterile, Pouched)