ENFit Syringe 3ml 101033160

GUDID 00020451101323

MEDELA, INC.

ENFit oral/enteral syringe, single-use

• Primary Device ID: 00020451101323
• NIH Device Record Key: 77f697a2-c082-4a6a-a0b6-171d6115c9b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENFit Syringe 3ml
• Version Model Number: ENF03LD
• Catalog Number: 101033160
• Company DUNS: 052002029
• Company Name: MEDELA, 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020451101323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161811

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: 2024-05-14
• Device Publish Date: 2024-05-06

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