AccessGUDID - DEVICE: ENTAKE (20653405055508)

GUDID

Device Identifier (DI) Information

Brand Name: ENTAKE
Version or Model: FEAC2000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FEAC2000
Company Name: Conmed Corporation

Primary DI Number: 20653405055508
Issuing Agency: GS1
Commercial Distribution End Date: April 04, 2023
Device Count: 10
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: PEG TUBING CLAMP

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?
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 [?]
K061021	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
Catheter Gauge: 20 French
Catheter Gauge: 24 French
Catheter Gauge: 18 French

Device Record Status

Public Device Record Key: 12d0029b-53a0-47fc-844e-0892dd621568
Public Version Date: April 05, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016