Ameritus AEG10-KMS

GUDID 30817522010001

10ml enteral/oral syringe

KENTEC MEDICAL, INC.

Oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use ENFit oral/enteral syringe, single-use

• Primary Device ID: 30817522010001
• NIH Device Record Key: 01e6a059-0a48-40d7-b27b-7754a27314f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ameritus
• Version Model Number: AEG10-KMS
• Catalog Number: AEG10-KMS
• Company DUNS: 066175613
• Company Name: KENTEC MEDICAL, 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: true
• 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: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817522010007 [Primary]
GS1	20817522010004 [Package]; Contains: 10817522010007; Package: box [100 Units]; In Commercial Distribution
GS1	30817522010001 [Package]; Contains: 10817522010007; Package: case [1200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110853

FDA Product Code

• FPD: Tube, Feeding

Sterilization

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

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

[30817522010001]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-22
• Device Publish Date: 2016-08-03

On-Brand Devices [Ameritus]

• 30817522011305: 60ml enteral/oral syringe
• 30817522011299: 5ml enteral/oral syringe
• 30817522011282: 3ml enteral/oral syringe
• 30817522011275: 30ml enteral/oral syringe
• 30817522011268: 20ml enteral/oral syringe
• 30817522011251: 1ml enteral/oral syringe
• 30817522010001: 10ml enteral/oral syringe
• 30817522012821: Enfit syringe straw
• 30817522010605: oral syringe straw