AccessGUDID - DEVICE: Replaceable Inner Tubes (07290018632116)

GUDID

Device Identifier (DI) Information

Brand Name: Replaceable Inner Tubes
Version or Model: FG-20F-ORANGE-REP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG-20F-ORANGE-REP
Company Name: FIDMI MEDICAL LTD

Primary DI Number: 07290018632116
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 600363369 *Terms of Use

Device Description: The Replacement Feeding Tube is designed to be replaced when needed. It is attached to the placed PEG device as it is slid into its location within the tube resulting in its distal end to reach the distal end of the main tube and internal bumper thus allowing the required substances (food or medications) to be inserted directly into the stomach.

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
62495	Enteral tube extension, non-sterile	A non-sterile, thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
No Device Sizes

Device Record Status

Public Device Record Key: 92723ec4-1fe9-4761-80c4-f144697d2134
Public Version Date: August 23, 2021
Public Version Number: 1
DI Record Publish Date: August 15, 2021