CORTRAK® 2 + CORGRIPTM Combo Pak

Basic Information

• Brand Name: CORTRAK® 2 + CORGRIPTM Combo Pak
• Primary DI: 10815149021932
• Version / Model: 45-9432TRAK-PAK
• Catalog Number: 45-9432TRAK-PAK
• Company Name: CORPAK MEDSYSTEMS, INC.
• Labeler DUNS: 147530323
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-28
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 027e87c3-051f-4ffc-b7f1-c46d00c405b5

Device Description

CORTRAK feeding tube and CORGRIP tube retention system, with ENFit Connectors

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: Yes
• 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
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59081	Enteral tube tracking system transmitter stylet	A non-sterile, thin, flexible wire with an electromagnetic (EM) transmitter at the distal end that is a component of an enteral tube tracking system and intended to be used as a stylet for an enteral feeding tube with which it is supplied. It is designed to facilitate the placement of the enteral tube by providing a signal used to create a graphic display representing the path of the tube tip. During use it is typically connected to a visual display/control unit and is used with an electromagnetic transmission receiver placed on the epigastrium. This is a reusable device intended for single-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20815149021939	GS1		5	In Commercial Distribution
Primary	10815149021932	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	12	French
Device Size Text, specify			12 FR (4 mm) x 43" (109cm)
Length	43	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: No