EndoVive™ One Step Button™

Basic Information

• Brand Name: EndoVive™ One Step Button™
• Primary DI: 08714729149217
• Version / Model: M00568470
• Catalog Number: M00568470
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-07
• Public Version: 1
• Public Version Date: 2018-10-08
• Public Version Status: New
• Public Device Record Key: 4497f553-caa4-4c53-9c1c-dd0c7a359ab9

Device Description

Low Profile Percutaneous Endoscopic Gastrostomy Kit

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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGC	TUBE, GASTRO-ENTEROSTOMY	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11677	Enteral feeding kit, adult/paediatric, sterile	A collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729149217	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6.0 mm Diameter
Device Size Text, specify			18 F Diameter
Device Size Text, specify			3.4 cm Length