AccessGUDID - DEVICE: Bard Button Replacement Gastrostomy Device (10801741087902)

GUDID

Device Identifier (DI) Information

Brand Name: Bard Button Replacement Gastrostomy Device
Version or Model: 000287
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 000287
Company Name: Bard Access Systems, Inc.

Primary DI Number: 10801741087902
Issuing Agency: GS1
Commercial Distribution End Date: January 26, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: 24 Fr x 3.4cm Button Kit

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:	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
Catheter Gauge: 24 French
Length: 3.4 Centimeter

Device Record Status

Public Device Record Key: 255812bd-afb0-4459-b668-e9ec97042c8d
Public Version Date: April 17, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2015