AccessGUDID - DEVICE: Bard Jejunal Feeding/Gastric Decompression Tube (00801741051630)

GUDID

Device Identifier (DI) Information

Brand Name: Bard Jejunal Feeding/Gastric Decompression Tube
Version or Model: 000319
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 000319
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741051630
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: 9 Fr Tether J-Tube

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:	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?
47656	Gastrojejunostomy tube	A thin, flexible, hollow tube intended to be percutaneously inserted into the stomach, typically through puncture of the abdominal wall and stomach after distention of the stomach by endoscopic methods, with an extended portion inserted through the pylorus into the jejunum, to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect or a neuromuscular condition) and/or to provide drainage/decompression for an obstructed stomach; it may also be used to administer medication to a patient. Additional invasive devices used to assist gastrostomy and tube introduction (e.g., guidewire) may be included with the tube. This is a single-use device.	Active	true

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: 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: 9 French
Length: 69 Centimeter

Device Record Status

Public Device Record Key: 15fb9849-964e-4728-8ea0-2a48ad8fc48f
Public Version Date: April 17, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2015