FDA.reportPublic FDA data

AMT Enfit® Transition Adapter

Primary DI
00842071108021
Brand
AMT Enfit® Transition Adapter
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
ETRN202
Catalog number
ETRN202, TRN202
Device description
Female Catheter-to-Female Enfit® Adapter (Pouched)
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PIOEnteral Specific Transition Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIOEnteral Specific Transition ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150034000AMT Enteral Transition AdaptersApplied Medical Technology, Inc.2015-06-09PIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842071109080PackageGS110In Commercial Distribution
00842071108021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071109080008420711090808420711090800842071109080
00842071108021008420711080218420711080210842071108021

GMDN Terms#

Term, Definition table
TermDefinition
ENFit/non-ISO80369-standardized linear connectorA small, non-powered, noninvasive, tubular two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a connection which is not designed according to ISO 80369 at the other end (typically barbed, conical, ENLock, threaded or non-Luer-slip), intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection typically with tubing or syringe; it does not connect a vial/bottle (i.e., not a vial/bottle adaptor). It does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.

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
00842071133245ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133252ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133269ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133276ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133283ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133290ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133306ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133313ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133320ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133337ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133344ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133351ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
10192253009644KangarooCardinal Health 200, LLCPIO2024-03-26
20192253009641KangarooCardinal Health 200, LLCPIO2024-03-26
10888277314719MedlineMEDLINE INDUSTRIES, INC.PIO2022-12-02
40888277314710MedlineMEDLINE INDUSTRIES, INC.PIO2022-12-02
10884389196915MedlineMEDLINE INDUSTRIES, INC.PIO2020-12-17
40884389196916MedlineMEDLINE INDUSTRIES, INC.PIO2020-12-17
08056093721096Enteral distal end ENFit Transition ConnectorCEDIC SRLPIO2020-03-11
08056093720549Enteral distal end ENFit Transition ConnectorCEDIC SRLPIO2020-03-11
08056093720716Enteral distal end ENFit Transition ConnectorCEDIC SRLPIO2019-08-20
08056093720723AVANOSCEDIC SRLPIO2019-08-20
08056093721072ENConnect 40 mm Screw Cap to ENPlus Adapter CEDIC SRLPIO2019-06-06
08056093720563ENConnect Male Distal End Stepped AdapterCEDIC SRLPIO2019-01-29
08056093720594ENConnect ENFit Funnel Adapter CEDIC SRLPIO2019-01-29
08056093720686ENConnect ENFit to Oral/Luer syringe adapterCEDIC SRLPIO2019-01-29
08056093720709ENConnect ENFit to Oral/Luer syringe adapterCEDIC SRLPIO2019-01-29
00857915006128EnsoETMAdvanced Cooling Therapy, LLCPIO2018-09-08
20857915006122EnsoETMAttune MedicalPIO2018-09-08
08056093720297Enteral Funnel ENFIt Transition Connector with capCEDIC SRLPIO2018-07-03