Device
24FR x 2.7 cm MINI Balloon Button Kit, MDR
Manufacturer
APPLIED MEDICAL TECHNOLOGY, INC.
APPLIED MEDICAL TECHNOLOGY, INC.
Model: 5-2427
DI: 00842071147198
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
24FR x 2.7 cm MINI Balloon Button Kit, MDR
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
67c597bb-347a-4df2-86b1-71cbbfe02cdb
Distribution Status:
In Commercial Distribution
DUNS Number:
038101861
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
00842071147198
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38565
Name: Gastrostomy button
Definition:
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.
FDA Product Codes
KNT
Tubes, Gastrointestinal (And Accessories)
Premarket Submissions
Item #1 - Submission Number:
K161413
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K945618
Item #2 - Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Centimeter
Item #1 - Size - @attributes - Value:
2.7
Item #1 - Size Type:
Length
Item #2 - Size - @attributes - Unit:
French
Item #2 - Size - @attributes - Value:
24
Item #2 - Size Type:
Catheter Gauge