AccessGUDID - DEVICE: CORFLO cuBBy (10815149024452)

GUDID

Device Identifier (DI) Information

Brand Name: CORFLO cuBBy
Version or Model: 35-9024
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 35-9024
Company Name: CORPAK MEDSYSTEMS, INC.

Primary DI Number: 10815149024452
Issuing Agency: GS1
Commercial Distribution End Date: August 06, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 147530323 *Terms of Use

Device Description: Feeding set for use with CORFLO cuBBy

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?
62256	Enteral tube extension, single-use	A thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube, gastrostomy tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. It is typically a single-lumen, rubber or plastic tube of various diameters/lengths. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 24" (61cm)
Length: 24 Inch

Device Record Status

Public Device Record Key: 57c19df1-7976-4b27-8bf6-1a03adc26162
Public Version Date: December 23, 2024
Public Version Number: 4
DI Record Publish Date: August 04, 2016