FDA.report

Medline

Primary DI
40888277314710
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
ENFIT1010GC
Catalog number
ENFIT1010GC
Device description
ENFIT G-TUBE CONNECTOR, MEDLINE
Published
2022-12-02
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

Related Records

Contact Domains

Product Codes

CodeName
PIOEnteral specific transition connectors

Product Code Classifications

CodeDeviceSpecialtyClass
PIOEnteral Specific Transition ConnectorsGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40888277314710PackageGS130In Commercial Distribution
10888277314719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4088827731471040888277314710
1088827731471910888277314719

GMDN Terms

TermDefinition
ENFit/ENFit 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 both ends intended to connect two enteral devices (e.g., enteral syringe, feeding tube, administration set) with each other; 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Protect from Freezing. Avoid excessive heat.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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 DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
20192253009641KangarooCardinal Health 200, LLCPIO2024-03-26
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
08056093720709ENConnect ENFit to Oral/Luer syringe adapterCEDIC SRLPIO2019-01-29
20857915006122EnsoETMAttune MedicalPIO2018-09-08
08056093720464Enteral Distal End ENFit Transition ConnectorCEDIC SRLPIO2018-05-04
08056093720037ENFit to Reverse Luer Transition ConnectorCEDIC SRLPIO2017-12-28
08056093720075Luer to ENFit Transition ConnectorCEDIC SRLPIO2017-12-28
08056093720136Enteral ENFit Transition Connector with cap for medication portCEDIC SRLPIO2017-12-28
08056093720167Enteral Funnel ENFit Transition Connector with capCEDIC SRLPIO2017-12-28
08056093720365Oral/Luer ENFit Transition Connector for medication portCEDIC SRLPIO2017-12-28
10884521212107KangarooCardinal Health, Inc.PIO2016-09-24
00842071109059AMT Enfit® Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2016-08-31
00842071109066AMT Enfit® Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2016-08-31
00842071109073AMT Enfit® Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2016-08-31
00842071109080AMT Enfit® Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2016-08-31
00842071109097AMT Enfit® Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2016-08-31
00842071109110AMT Enfit® Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2016-08-31