AccessGUDID - DEVICE: EndoVive Jejunal Feeding Tube (08714729789666)

GUDID

Device Identifier (DI) Information

Brand Name: EndoVive Jejunal Feeding Tube
Version or Model: M00566340
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729789666
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: 3-Port Through-the-PEG J-Tube 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":	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)
FPD	TUBE, FEEDING

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
Device Size Text, specify: 68 cm Effective Length
Device Size Text, specify: 12 F Diameter
Device Size Text, specify: 4.0 mm Diameter

Device Record Status

Public Device Record Key: ea9a5674-0bbe-4f73-ad43-c8e9eb4f6a1b
Public Version Date: April 08, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016