FDA.reportPublic FDA data

ENFit Transition Adapter

Primary DI
00842071133306
Brand
ENFit Transition Adapter
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
ETRN101
Catalog number
ETRN101, TRN101
Device description
Male ENFit-to-Male Luer Adapter (Pouched), MDR
Published
2025-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00842071133306PackageGS110In Commercial Distribution
00842071133245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071133306008420711333068420711333060842071133306
00842071133245008420711332458420711332450842071133245

GMDN Terms#

Term, Definition table
TermDefinition
ENFit/Luer 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 Luer connection (either lock or slip) at the other end, intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with ENFit connection with another device that has Luer connection. It does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

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
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00842071146474MINI Balloon Button5-16275-16272026-10-22
00842071146481MINI Balloon Button5-1627-I5-1627-I2026-10-22
00842071146498MINI Balloon Button5-16305-16302026-10-22
00842071146504MINI Balloon Button5-1630-I5-1630-I2026-10-22
00842071146535MINI Balloon Button5-16405-16402026-10-22
00842071146542MINI Balloon Button5-1640-I5-1640-I2026-10-22
00842071147075MINI Balloon Button5-20445-20442026-10-22
00842071147082MINI Balloon Button5-2044-I5-2044-I2026-10-22
00842071147259MINI Balloon Button5-24405-24402026-10-22
00842071147266MINI Balloon Button5-2440-I5-2440-I2026-10-22
00842071146337MINI Balloon Button5-16105-16102026-10-20
00842071146344MINI Balloon Button5-1610-I5-1610-I2026-10-20
00842071146375MINI Balloon Button5-16155-16152026-10-20
00842071146382MINI Balloon Button5-1615-I5-1615-I2026-10-20
00842071146795MINI Balloon Button5-18445-18442026-10-20
00842071146801MINI Balloon Button5-1844-I5-1844-I2026-10-20
00842071147136MINI Balloon Button5-24205-24202026-10-20
00842071147143MINI Balloon Button5-2420-I5-2420-I2026-10-20
00842071147150MINI Balloon Button5-24235-24232026-10-20
00842071147167MINI Balloon Button5-2423-I5-2423-I2026-10-20

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
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
00857915006203EnsoETMAdvanced Cooling Therapy, LLCPIO2018-05-17