AccessGUDID - DEVICE: MiniONE Balloon Button (00842071142254)

GUDID

Device Identifier (DI) Information

Brand Name: MiniONE Balloon Button
Version or Model: M1-5-2450-I
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M1-5-2450-I
Company Name: APPLIED MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00842071142254
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038101861 *Terms of Use

Device Description: 24FR x 5.0 cm MiniONE Balloon Button - Low Profile Feeding Device (ENFit), MDR

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?
38565	Gastrostomy button	A sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. 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 [?]
K161413	000
K945618	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: 5.0 Centimeter
Catheter Gauge: 24 French

Device Record Status

Public Device Record Key: b1c23649-9459-4529-a25b-c9419c6061b3
Public Version Date: November 04, 2024
Public Version Number: 1
DI Record Publish Date: October 25, 2024