AccessGUDID - DEVICE: Y-Connector for AbbVie PEG 15 FR (08054083004907)

GUDID

Device Identifier (DI) Information

Brand Name: Y-Connector for AbbVie PEG 15 FR
Version or Model: 62924
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ABBVIE INC.

Primary DI Number: 08054083004907
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078458370 *Terms of Use

Device Description: The saleable unit (device count) is 1, there are 5 Y-Connectors in the saleable unit

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:	No
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?
38564	Jejunostomy tube	A sterile, thin, flexible, hollow tube percutaneously inserted into the jejunum, typically through puncture of the abdominal wall and stomach after distention of the gut by endoscopic methods. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and/or to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine. 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 [?]
K142816	000

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: 15310592-a050-491d-937b-83934a462662
Public Version Date: October 07, 2019
Public Version Number: 2
DI Record Publish Date: April 15, 2019