FDA.reportPublic FDA data

AMT Bridle™ Pro

Primary DI
00842071115876
Brand
AMT Bridle™ Pro
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
E4-420810
Catalog number
E4-420810, 4-420810
Device description
8 - 10 FR AMT Bridle Pro Nasal Tube Retaining System (Pouched)
Published
2016-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
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
K030784000
K142971000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030784000NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVALApplied Medical Technology, Inc.2004-04-01KNT
K142971000AMT Bridle - Nasal Tube Retention SystemApplied Medical Technology, Inc.2015-05-26KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071115913PackageGS15In Commercial Distribution
00842071115876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071115913008420711159138420711159130842071115913
00842071115876008420711158768420711158760842071115876

GMDN Terms#

Term, Definition table
TermDefinition
Nasogastric tube holder, noninvasiveA small, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient. It is typically designed as an adhesive plaster with wings that are attached to the face (e.g., across the bridge of the nose, on the cheeks). It may have a lock-ring or non-adhesive tabs that is/are attached to the nasogastric tube (placed through a nostril and via the oesophagus) to hold it safely and comfortably in place. The lock-ring or tabs can be removed without scissors for easy removal of the tube. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Catheter Gauge10French

Contacts#

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

Regulatory Flags#

DUNS number
038101861
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842071132163MiniACE Low Profile Antegrade Continence Enema Irrigation SetE2-1221E2-1221, 2-12212024-06-26
00842071132170MiniACE Low Profile Antegrade Continence Enema Irrigation SetE2-1221-ISOSAFE2-1221-ISOSAF, 2-1221-ISOSAF2024-06-26
00842071132187MiniACE Low Profile Antegrade Continence Enema Irrigation SetE2-2421E2-2421, 2-24212024-06-26
00842071132194MiniACE Low Profile Antegrade Continence Enema Irrigation SetE2-2421-ISOSAFE2-2421-ISOSAF, 2-2421-ISOSAF2024-06-26
00842071136642MiniACEACE-1008ACE-10082024-08-30
00842071136659MiniACEACE-1008-IACE-1008-I2024-08-30
00842071136666MiniACEACE-1010ACE-10102024-08-30
00842071136673MiniACEACE-10100ACE-101002024-08-30
00842071136680MiniACEACE-10100-IACE-10100-I2024-08-30
00842071136697MiniACEACE-1010-IACE-1010-I2024-08-30
00842071136703MiniACEACE-1012ACE-10122024-08-30
00842071136710MiniACEACE-1012-IACE-1012-I2024-08-30
00842071136727MiniACEACE-1015ACE-10152024-08-30
00842071136734MiniACEACE-1015-IACE-1015-I2024-08-30
00842071136741MiniACEACE-1017ACE-10172024-08-30
00842071136758MiniACEACE-1017-IACE-1017-I2024-08-30
00842071136765MiniACEACE-1020ACE-10202024-08-30
00842071136772MiniACEACE-1020-IACE-1020-I2024-08-30
00842071136789MiniACEACE-1023ACE-10232024-08-30
00842071136796MiniACEACE-1023-IACE-1023-I2024-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071136642MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136659MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136666MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136673MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136680MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136697MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136703MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136710MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071136727MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-08-30
00842071132163MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132170MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132187MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
00842071132194MiniACE Low Profile Antegrade Continence Enema Irrigation SetAPPLIED MEDICAL TECHNOLOGY, INC.KNT2024-06-26
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00842071121143MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121150MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121167MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121174MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121181MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
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00842071121204MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
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00842071121228MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121235MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121242MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121259MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11
00842071121266MiniACE®APPLIED MEDICAL TECHNOLOGY, INC.KNT2019-10-11