AccessGUDID - DEVICE: Micro G-Jet® (00842071124717)

GUDID

Device Identifier (DI) Information

Brand Name: Micro G-Jet®
Version or Model: MGJ-1408-15-I
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MGJ-1408-15-I
Company Name: APPLIED MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00842071124717
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038101861 *Terms of Use

Device Description: 14FR x 0.8 cm x 15 cm - AMT micro G-Jet® Low Profile Transgastric-Jejunal Feeding Device (ENFit®)

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":	Yes
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
PIF	Gastrointestinal Tubes With Enteral Specific Connectors
KNT	Tubes, Gastrointestinal (And Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183508	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
Length: 0.8 Centimeter
Catheter Gauge: 14 French
Length: 15 Centimeter
Catheter Gauge: 8 French

Device Record Status

Public Device Record Key: 3107cdc6-9277-4479-a4d6-0035c163195a
Public Version Date: April 08, 2022
Public Version Number: 2
DI Record Publish Date: December 06, 2019