AccessGUDID - DEVICE: CORLITE Enteral Feeding Tube Extension Set (10815149022021)

GUDID

Device Identifier (DI) Information

Brand Name: CORLITE Enteral Feeding Tube Extension Set
Version or Model: 41-1030Y
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 41-1030Y
Company Name: CORPAK MEDSYSTEMS, INC.

Primary DI Number: 10815149022021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 147530323 *Terms of Use

Device Description: Feeding extentions set with ENFit connectors and InlineY site

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":	Yes
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?
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.	Obsolete	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: 30 Inch
Device Size Text, specify: 30" (76cm)

Device Record Status

Public Device Record Key: 1bccfd64-d455-4313-bbcf-453bc0ab7a43
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 24, 2016