AccessGUDID - DEVICE: EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector (00813939023787)

GUDID

Device Identifier (DI) Information

Brand Name: EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector
Version or Model: M00510020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-0053-224
Company Name: XERIDIEM MEDICAL DEVICES, INC.

Primary DI Number: 00813939023787
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 183325125 *Terms of Use

Device Description: EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector, 24FR

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
35419	Gastrostomy tube	A thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PIF	Gastrointestinal Tubes With Enteral Specific Connectors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142075	000

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: 33f445be-d511-4d00-a261-e0e8691b0244
Public Version Date: April 20, 2020
Public Version Number: 5
DI Record Publish Date: August 03, 2016