Ameritus ENFit ENF20-KSBA

GUDID 30817522010650

20ml enfit non-sterile amber 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: 30817522010650
• NIH Device Record Key: 305367b5-ef09-4eea-b27b-56386d9a831b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ameritus ENFit
• Version Model Number: ENF20-KSBA
• Catalog Number: ENF20-KSBA
• Company DUNS: 066175613
• Company Name: KENTEC MEDICAL, INC.
• Device Count: 50
• 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: false
• 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	00817522010659 [Unit of Use]
GS1	10817522010656 [Primary]
GS1	20817522010653 [Package]; Contains: 10817522010656; Package: box` [200 Units]; In Commercial Distribution
GS1	30817522010650 [Package]; Contains: 10817522010656; Package: case [800 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162188

FDA Product Code

• PNR: Enteral Syringes 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: 4
• Public Version Date: 2020-01-22
• Device Publish Date: 2019-03-28

On-Brand Devices [Ameritus ENFit]

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• 30817522011534: 30ml enfit non-sterile clear syringe
• 30817522011527: 20ml enfit non-sterile clear syringe
• 30817522011510: 10ml enfit non-sterile clear syringe
• 30817522011503: 5ml enfit low dose non-sterile clear syringe
• 30817522011497: 3ml enfit low dose non-sterile clear syringe
• 30817522011480: 1ml enfit low dose non-sterile clear syringe
• 30817522011473: 60ml enfit non-sterile amber syringe
• 30817522011466: 30ml enfit non-sterile amber syringe
• 30817522010650: 20ml enfit non-sterile amber syringe
• 30817522010643: 10ml enfit non-sterile amber syringe
• 30817522010636: 3ml enfit low dose non-sterile amber syringe
• 30817522010629: 5ml enfit low dose non-sterile amber syringe
• 30817522010612: 1ml enfit low dose non-sterile amber syringe
• 30817522013231: Enfit syringe cap
• 30817522013101: 6fr 90cm dual port feeding tube with ENFit connector
• 30817522012364: 5fr 40cm dual port feeding tube with ENFit connectors
• 30817522012784: 60ml enfit enteral feeding syringe
• 30817522012777: 30ml enfit enteral feeding syringe
• 30817522012760: 20ml enfit enteral feeding syringe
• 30817522012753: 10ml enfit enteral feeding syringe
• 30817522012746: 5ml enfit enteral feeding syringe-low dose
• 30817522012739: 3ml enfit enteral feeding syringe-low dose
• 30817522012722: 1ml enfit enteral feeding syringe-low dose
• 30817522012357: 8fr 80cm single port feeding tube with ENFit connector