AccessGUDID - DEVICE: Low Profile Enteral Feeding Device Kit (07290018632017)

GUDID

Device Identifier (DI) Information

Brand Name: Low Profile Enteral Feeding Device Kit
Version or Model: FG-20F- ORANGE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG-20F- ORANGE
Company Name: FIDMI MEDICAL LTD

Primary DI Number: 07290018632017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600363369 *Terms of Use

Device Description: The Fidmi Medical Low Profile Gastrostomy Device is a single use, sterile, disposable device, that allows for enteral nutriton and / or medicaton delivery directly into the stomach. The PEG placement kit is supplied with the components needed for device placement.

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?
38565	Gastrostomy button	A sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KGC	Tube, Gastro-Enterostomy

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: 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: a8f5408f-cd7e-442c-a15a-0da4900d4203
Public Version Date: August 23, 2021
Public Version Number: 1
DI Record Publish Date: August 15, 2021