Medline

Basic Information

• Brand Name: Medline
• Primary DI: 07290110061852
• Version / Model: 103310081289MD
• Company Name: DEGANIA SILICONE LTD
• Labeler DUNS: 600007082
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-11
• Public Version: 1
• Public Version Date: 2024-02-19
• Public Version Status: New
• Public Device Record Key: 08d56514-843b-4f41-9091-534b828fd4ae

Device Description

Gastrostomy Button G1I 2.5cm 12Fr ENFit Big Blis

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
38565	Gastrostomy button	A sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27290110061856	GS1		1	In Commercial Distribution
Primary	07290110061852	GS1
Package	47290110061850	GS1		5	In Commercial Distribution