FDA.reportPublic FDA data

MINI Balloon Button

Primary DI
00842071146641
Brand
MINI Balloon Button
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
5-1817-I
Catalog number
5-1817-I
Device description
18FR x 1.7 cm MINI Balloon Button Kit (ENFit), MDR
Published
2026-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161413000
K945618000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161413000Low Profile Balloon Feeding DeviceApplied Medical Technology, Inc.2017-02-09KNT
K945618000GASTROINTESTINAL TUBES & ACCESSORIESApplied Medical Technologies1995-10-12KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071146641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071146641008420711466418420711466410842071146641

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy buttonA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Length0

Contacts#

Phone, Email table
PhoneEmail
(440)717-4000cs@appliedmedical.net

Regulatory Flags#

DUNS number
038101861
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071146634MINI Balloon Button5-18175-18172026-10-19
00842071146672MINI Balloon Button5-18235-18232026-10-19
00842071146689MINI Balloon Button5-1823-I5-1823-I2026-10-19
00842071146696MINI Balloon Button5-18255-18252026-10-19
00842071146702MINI Balloon Button5-1825-I5-1825-I2026-10-19
00842071146719MINI Balloon Button5-18275-18272026-10-19
00842071146726MINI Balloon Button5-1827-I5-1827-I2026-10-19
00842071146733MINI Balloon Button5-18305-18302026-10-19
00842071146740MINI Balloon Button5-1830-I5-1830-I2026-10-19
00842071146757MINI Balloon Button5-18355-18352026-10-19
00842071146764MINI Balloon Button5-1835-I5-1835-I2026-10-19
00842071146771MINI Balloon Button5-18405-18402026-10-19
00842071146788MINI Balloon Button5-1840-I5-1840-I2026-10-19
00842071146979MINI Balloon Button5-20255-20252026-10-19
00842071146986MINI Balloon Button5-2025-I5-2025-I2026-10-19
00842071136383AMT Stiffener for Initial PlacementE4-6010E4-6010, 4-60102026-10-16
00842071145774MINI Balloon Button5-12105-12102026-10-09
00842071145781MINI Balloon Button5-1210-I5-1210-I2026-10-09
00842071146573MINI Balloon Button5-18105-18102026-10-09
00842071146580MINI Balloon Button5-1810-I5-1810-I2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071146634MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146672MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146689MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146696MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146702MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146719MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146726MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146733MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146740MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146757MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146764MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146771MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146788MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146979MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071146986MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-19
00842071136383AMT Stiffener for Initial PlacementAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-16
00350770997742MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTWAvanos Medical, Inc.KNT2026-10-14
00350770997759MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, OTWAvanos Medical, Inc.KNT2026-10-14
00350770997766MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, OTWAvanos Medical, Inc.KNT2026-10-14
00350770997773MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, OTWAvanos Medical, Inc.KNT2026-10-14
00350770997803MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997810MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997827MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997865MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997872MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997889MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997926MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997933MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997940MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-14
00350770997957MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-14