NUTRIFIT

GUDID 18015262035416

Enteral ENFit syringe 60ml

PENTAFERTE ITALIA SRL

ENFit oral/enteral syringe, single-use

• Primary Device ID: 18015262035416
• NIH Device Record Key: 9ce53b36-4b80-4c5d-afc9-42a1a9bb00d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NUTRIFIT
• Version Model Number: 1015.607
• Company DUNS: 434304126
• Company Name: PENTAFERTE ITALIA SRL
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08015262035419 [Primary]
GS1	18015262035416 [Package]; Contains: 08015262035419; Package: [60 Units]; In Commercial Distribution
GS1	28015262035413 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161141

FDA Product Code

• PNR: Enteral Syringes With Enteral Specific Connectors

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: 2025-03-20
• Device Publish Date: 2025-03-12

On-Brand Devices [NUTRIFIT]

• 18015262039308: Enteral ENFit syringe 1ml
• 28015262035482: Enteral ENFit syringe 100ml
• 18015262035416: Enteral ENFit syringe 60ml
• 18015262020139: Enteral ENFit syringe 10ml
• 18015262020115: Enteral ENFit syringe 20ml