AccessGUDID - DEVICE: CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube (10815149020997)

GUDID

Device Identifier (DI) Information

Brand Name: CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube
Version or Model: 42-9558TRAK2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 42-9558TRAK2
Company Name: CORPAK MEDSYSTEMS, INC.

Primary DI Number: 10815149020997
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 147530323 *Terms of Use

Device Description: Feeding tube with stylet for use with CORTRAK 2 Enteral Access System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: No

Clinically Relevant Size

[?]

Size Type Text
Length: 55 Inch
Device Size Text, specify: 8 FR (2.7mm )X 55" (140cm)
Catheter Gauge: 8 French

Device Record Status

Public Device Record Key: c7a16783-7748-4b4d-a11c-67f4771ecc23
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 24, 2016