Sentinel®

Basic Information

• Brand Name: Sentinel®
• Primary DI: 00896406002362
• Version / Model: S-2000-6
• Catalog Number: S-2000-6
• Company Name: ALCOR SCIENTIFIC INC.
• Labeler DUNS: 884153748
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-03
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d61570fc-77a0-48c7-8af0-82340c3cda1e

Device Description

Sentinel®, Enteral Feeding Pump, 230VAC Type BF

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZH	Pump, Infusion, Enteral	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13209	Enteral feeding pump	A mains electricity (AC-powered) device designed to create pressure to accurately control the rates of flow of nutrient fluids directly into the stomach, duodenum, or jejunum, via enteral tubing, in patients who are unable or unwilling to consume adequate nutrients.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00896406002362	GS1

Premarket Submissions

Submission Number	Supplement Number
K011587	000