FDA.reportPublic FDA data

Enteral ENFit Transition Connector with cap for medication port

Primary DI
08056093720136
Brand
Enteral ENFit Transition Connector with cap for medication port
Company
CEDIC SRL
Model
F00073
Published
2017-12-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PIOEnteral Specific Transition Connectors

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056093720129PackageGS130Not in Commercial Distribution
08056093720136PackageGS124Not in Commercial Distribution
08056093720112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056093720129080560937201298056093720129
08056093720136080560937201368056093720136
08056093720112080560937201128056093720112

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

Regulatory Flags#

DUNS number
429471691
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
08056093720013ENFit to Reverse Luer Transition ConnectorF001262017-12-28
08056093720051Luer to ENFit Transition ConnectorF001282017-12-28
08056093720037ENFit to Reverse Luer Transition ConnectorF001262017-12-28
08056093720075Luer to ENFit Transition ConnectorF001282017-12-28
08056093720327Enteral Distal End ENFit Transition ConnectorF000902018-05-04
08056093720464Enteral Distal End ENFit Transition ConnectorF000902018-05-04
08056093720112Enteral ENFit Transition Connector with cap for medication portF000732017-12-28
08056093720143Enteral Funnel ENFit Transition Connector with capF000742017-12-28
08056093721096Enteral distal end ENFit Transition ConnectorG449892020-03-11
08056093720716Enteral distal end ENFit Transition Connector7149 002019-08-20
08056093720549Enteral distal end ENFit Transition ConnectorG449892020-03-11
08056093720167Enteral Funnel ENFit Transition Connector with capF000742017-12-28
08056093720839Compat Junior Enteral Feeding tube 8Fr 76cm with styletN3552019-12-13
08056093720853Compat Enteral Feeding tube 8Fr 120cmN3602019-12-13
08056093720877Compat Enteral Feeding tube 8Fr 120cm with styletN3652019-12-13
08056093720891Compat Enteral Feeding tube 10Fr 120cmN4502019-12-13
08056093720914Compat Enteral Feeding tube 10Fr 120cm with styletN4552019-12-13
08056093720938Compat Enteral Feeding tube 12Fr 90cmN5502019-12-13
08056093720952Compat Enteral Feeding tube 12Fr 120cmN5552019-12-13
08056093720976Compat Enteral Feeding tube 12Fr 120cm with styletN5602019-12-13

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