Enteral Feeding

GUDID 30020451330946

3mL Non-Sterile Enteral/Oral Syringe with ENFit Low Dose Tip

MEDELA, INC.

Oral/enteral syringe, single-use

• Primary Device ID: 30020451330946
• NIH Device Record Key: 7784b846-ca8b-4b7a-b663-ccf2a36ba9cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enteral Feeding
• Version Model Number: 101034138
• Company DUNS: 052002029
• Company Name: MEDELA, 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com
• Phone: (888)633-3528
• Email: cssupport@medela.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020451330945 [Primary]
GS1	20020451330949 [Package]; Contains: 00020451330945; Package: [10 Units]; In Commercial Distribution
GS1	30020451330946 [Package]; Contains: 20020451330949; Package: [6 Units]; In Commercial Distribution
GS1	40020451330943 [Unit of Use]

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: 6
• Public Version Date: 2020-01-22
• Device Publish Date: 2017-07-28

On-Brand Devices [Enteral Feeding]

• 20020451331625: Enteral Syringe 60 mL, Bonded TwistLok Connector
• 20020451331618: Enteral Syringe 30 mL, Bonded TwistLok Connector
• 20020451331601: Enteral Syringe 20 mL, Bonded TwistLok Connector
• 20020451331595: Enteral Syringe 10 mL, Bonded TwistLok Connector
• 20020451331588: Enteral Syringe 5 mL, Bonded TwistLok Connector
• 20020451331571: Enteral Syringe 3 mL, Bonded TwistLok Connector
• 20020451331489: Enteral Syringe Plunger, 60mL
• 20020451331472: Enteral Syringe Plunger, 30mL
• 20020451331465: Enteral Syringe Plunger, 10mL
• 20020451331458: Enteral GraviFeed Syringe, 60 mL, Slip Tip
• 20020451331441: Enteral GraviFeed Syringe, 60 mL, TwistLok
• 20020451331434: Enteral GraviFeed Syringe, 30 mL, Slip Tip
• 20020451331427: Enteral GraviFeed Syringe, 30 mL, TwistLok
• 20020451331410: Enteral GraviFeed Syringe, 10 mL, TwistLok
• 20020451331403: 60 mL Enteral Syringe Lid
• 20020451331397: 30 mL Enteral Syringe Lid
• 20020451331380: 10 mL Enteral Syringe Lid
• 20020451331366: Enteral Syringe 60mL, Bonded Slip Tip Connector
• 20020451331359: Enteral Syringe 30mL, Bonded Slip Tip Connector
• 20020451331342: Enteral Syringe 20mL, Bonded Slip Tip Connector
• 20020451331335: Enteral Syringe 10mL, Bonded Slip Tip Connector
• 20020451331328: Enteral Syringe 5mL, Bonded Slip Tip Connector
• 20020451331311: Enteral Syringe 3mL, Bonded Slip Tip Connector
• 20020451331304: Enteral Syringe 1 mL, Slip Tip Connector
• 20020451330987: Enteral Syringe 5mL, TwistLok
• 20020451330970: Enteral Syringe 30mL, TwistLok
• 20020451330963: Enteral Syringe 10mL, TwistLok
• 20020451330956: Enteral Syringe 60mL, TwistLok
• 30020451330946: 3mL Non-Sterile Enteral/Oral Syringe with ENFit Low Dose Tip
• 30020451330939: 1mL Non-Sterile Enteral/Oral Syringe with ENFit Low Dose Tip
• 20020451101242: Enteral Syringe 60 mL, Bonded TwistLok Connector
• 20020451101235: Enteral Syringe 30 mL, Bonded TwistLok Connector
• 20020451101228: Enteral Syringe 20 mL, Bonded TwistLok Connector
• 20020451101211: Enteral Syringe 10 mL, Bonded TwistLok Connector
• 20020451101204: Enteral Syringe 5 mL, Bonded TwistLok Connector
• 20020451101198: Enteral Syringe 3 mL, Bonded TwistLok Connector
• 20020451101068: Enteral Syringe Plunger, 60mL
• 20020451101051: Enteral Syringe Plunger, 30mL
• 20020451101044: Enteral Syringe Plunger, 10mL
• 20020451101037: Enteral Syringe 60mL, TwistLok
• 20020451101020: Enteral Syringe 30mL, TwistLok
• 20020451101013: Enteral Syringe 10mL, TwistLok
• 20020451101006: Enteral Syringe 5mL, TwistLok
• 20020451100979: Enteral GraviFeed Syringe, 60 mL, Slip Tip
• 20020451100962: Enteral GraviFeed Syringe, 60 mL, TwistLok
• 20020451100955: Enteral GraviFeed Syringe, 30 mL, Slip Tip
• 20020451100948: Enteral GraviFeed Syringe, 30 mL, TwistLok
• 20020451100931: Enteral GraviFeed Syringe, 10 mL, TwistLok
• 20020451100924: 60 mL Enteral Syringe Lid
• 20020451100917: 30 mL Enteral Syringe Lid