Enteral Feeding

Basic Information

• Brand Name: Enteral Feeding
• Primary DI: 00020451100364
• Version / Model: ENFMEDCAP
• Company Name: MEDELA, INC.
• Labeler DUNS: 052002029
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2018-08-16
• Public Version Status: Update
• Public Device Record Key: 36fe1ed3-84cd-491d-8b4a-58517c3714d7
• Distribution End Date: 2018-08-14

Device Description

Med Cap, ENFit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62178	Enteral feeding/medication connector, sterile	A sterile adaptor intended to enable connection of components of an enteral feeding and/or enteral medication administration kit (e.g., connection between tubing and syringe). It is typically a small plastic device containing a lumen to facilitate enteral administration after connection; it has no additional functionality and is dedicated to enteral administration applications. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20020451100368	GS1		50	Not in Commercial Distribution	2018-08-14
Primary	00020451100364	GS1
Unit of Use	40020451100362	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K894206	000