AccessGUDID - DEVICE: CORFLO Enteral Feeding Tube (10815149020195)

GUDID

Device Identifier (DI) Information

Brand Name: CORFLO Enteral Feeding Tube
Version or Model: 40-4432
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40-4432
Company Name: CORPAK MEDSYSTEMS, INC.

Primary DI Number: 10815149020195
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 ENFit connectors 7 gm weight and stylet

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?
14221	Nasogastric feeding tube	A sterile, thin, flexible, hollow cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily for enteral feeding and the administration of medications, either by gravity or with a pump; it may also be used for aspiration of gastric contents (e.g., gastric secretions). It is typically a single lumen, rubber or plastic tube of various diameters (typically smaller than those of nasogastric tubes intended primarily for decompression) with circular markings that serve as insertion guides. It is frequently used for very ill or comatose patients. This is a single-use device.	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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: No

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 861f55ff-4499-46c0-a2c7-4a5bdb9b5535
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 24, 2016