Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10193489143201
• Version / Model: ENFIT331215
• Catalog Number: ENFIT331215
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-05
• Public Version: 1
• Public Version Date: 2024-02-13
• Public Version Status: New
• Public Device Record Key: 3f60d7e9-9fd5-4b6b-9b29-a76d519beab3

Device Description

BALLOON BUTTON,MEDLINE,ENFIT,12FR,1.5CM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
PSH	Percutaneous replacement gastrostomy tube kit	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64464	Gastrostomy tube kit, non-medicated	A collection of devices which includes a gastrostomy tube and other instruments intended for short- and/or long-term (= 24 hours) access to the stomach via a gastrostomy; it does not include any pharmaceutical agents. In addition to the gastrostomy tube, the kit includes additional invasive devices designed to perform the gastrostomy and/or assist tube introduction (e.g., scalpel, introduction needle, stoma sizer, guidewire, dilator). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10193489143201	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Keep away from sunlight.