FDA.reportPublic FDA data

Gastrostomy Tube with ENFit connector

Primary DI
10888277411043
Brand
Gastrostomy Tube with ENFit connector
Company
MEDLINE INDUSTRIES, INC.
Model
ENFIT70316
Catalog number
70-0064-116
Device description
Gastrostomy Tube with ENFit connector, 16FR
Published
2016-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142075000BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBEXeridiem (Formerly Mri)2015-01-08PIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277411040PackageGS15In Commercial Distribution
10888277411043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827741104020888277411040
1088827741104310888277411043

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy tubeA thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(520) 882-7794smurray@xeridiem.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344205281CURADCUR47451RBCUR47451RB2026-10-29
00884389108362CURADCUR4025RCUR4025R2026-10-29
00884389108393CURADCUR4135RCUR4135R2026-10-29
00888277187088CURADCUR4125RCUR4125R2026-10-29
10197344148608MEDLINERTDCIVDHGRTDCIVDHG2026-10-29
10197344148615MEDLINERTDCIVDHNRTDCIVDHN2026-10-29
10197344148622MEDLINERTDCIVDHPRTDCIVDHP2026-10-29
10197344148639MEDLINERTDCIVDHRRTDCIVDHR2026-10-29
10197344148646MEDLINERTDCIVDHYRTDCIVDHY2026-10-29
10197344148653MEDLINERTDCIVDHZRTDCIVDHZ2026-10-29
10197344219278MEDLINEDYNDSCL3000RDYNDSCL3000R2026-10-29
10197344223862MEDLINEDYSNR24OVCOLDDYSNR24OVCOLD2026-10-29
10653160395690MEDLINEDYNDC3636DYNDC36362026-10-29
10653160395768MEDLINECVI5130BCVI5130B2026-10-29
10653160395874MEDLINEEBSI1161BEBSI1161B2026-10-29
10653160395935MEDLINEDYNDH2410DYNDH24102026-10-29
10653160395966MEDLINEEBSI1729BEBSI1729B2026-10-29
10653160396017MEDLINEEBSI1427BEBSI1427B2026-10-29
10653160396024MEDLINEDYNDC3648DYNDC36482026-10-29
10653160396031MEDLINEEBSI1840AEBSI1840A2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071136642MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136659MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136666MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136673MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136680MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136697MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136703MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136710MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136727MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136734MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136741MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136758MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136765MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136772MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136789MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136796MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136802MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136819MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136826MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136833MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136840MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136857MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136864MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136871MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136888MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136895MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136901MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136918MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136925MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30
00842071136932MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.PIF2024-08-30