FDA.reportPublic FDA data

MINI Balloon Button

Primary DI
00842071146665
Brand
MINI Balloon Button
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
5-1820-I
Catalog number
5-1820-I
Device description
18FR x 2.0 cm MINI Balloon Button Kit (ENFit), MDR
Published
2026-10-09
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
00842071146665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071146665008420711466658420711466650842071146665

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
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
00842071146610MINI Balloon Button5-18155-18152026-10-09
00842071146627MINI Balloon Button5-1815-I5-1815-I2026-10-09
00842071146658MINI Balloon Button5-18205-18202026-10-09
00842071146290MINI Balloon Button5-14605-14602026-09-29
00842071146306MINI Balloon Button5-1460-I5-1460-I2026-09-29
00842071146313MINI Balloon Button5-14655-14652026-09-29
00842071146320MINI Balloon Button5-1465-I5-1465-I2026-09-29
00842071146351MINI Balloon Button5-16125-16122026-09-29
00842071146368MINI Balloon Button5-1612-I5-1612-I2026-09-29
00842071146399MINI Balloon Button5-16175-16172026-09-29
00842071146405MINI Balloon Button5-1617-I5-1617-I2026-09-29
00842071146450MINI Balloon Button5-16255-16252026-09-29
00842071146467MINI Balloon Button5-1625-I5-1625-I2026-09-29
00842071146511MINI Balloon Button5-16355-16352026-09-29
00842071146528MINI Balloon Button5-1635-I5-1635-I2026-09-29
00842071146559MINI Balloon Button5-16445-16442026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071145774MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071145781MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146573MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146580MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146610MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146627MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00842071146658MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-10-09
00350770005881CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00350770007915CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00842071146290MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146306MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146313MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146320MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146351MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146368MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146399MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146405MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146450MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146467MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146511MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146528MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146559MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146566MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146597MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146603MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
G461CEGCT40M0EndolumikEndolumik, Inc.KNT2026-08-25
00350770006840CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770009094CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21