ENFit Syringe 1ml 101033159

GUDID 20020451101303

MEDELA, INC.

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 ENFit oral/enteral syringe, single-use

• Primary Device ID: 20020451101303
• NIH Device Record Key: 4cce06d8-cadb-4c39-97f9-d18a69b4232e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENFit Syringe 1ml
• Version Model Number: ENF01LD
• Catalog Number: 101033159
• 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

Customer Support Contacts

• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com
• Phone: 1-800-435-8316
• Email: customer.service@medela.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020451101309 [Primary]
GS1	20020451101303 [Package]; Contains: 00020451101309; Package: [100 Units]; In Commercial Distribution

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

Devices Manufactured by MEDELA, INC.

• 20020451464576 - 18mm PersonalFit™ Plus Breast shields: 2024-05-29
• 10020451464562 - 18mm PersonalFit™ Plus Breast shields: 2024-05-29
• 10020451464586 - PNSMX Resupply kits: 2024-05-29
• 10020451416240 - Solo™: 2024-05-23
• 10020451467099 - Swing Maxi™ Hands-free: 2024-05-22
• 20020451463623 - Pediatric Breast Pump Kit with Harmony: 2024-05-16
• 20020451464477 - Breast Pump Kit with Harmony & 80mL container: 2024-05-16
• 20020451101303 - ENFit Syringe 1ml: 2024-05-14
• 20020451101303 - ENFit Syringe 1ml: 2024-05-14