FDA.reportPublic FDA data

ENFit Transition Adapter

Primary DI
00842071133269
Brand
ENFit Transition Adapter
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
ETRN201
Catalog number
ETRN201, TRN201
Device description
Female Luer/Oral-to-Female ENFit 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
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
00842071133320PackageGS110In Commercial Distribution
00842071133269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842071133320008420711333208420711333200842071133320
00842071133269008420711332698420711332690842071133269

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
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
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
00857915006203EnsoETMAdvanced Cooling Therapy, LLCPIO2018-05-17