FDA.report

Gastrostomy Tube, 3 port, 20fr, ENFit

Primary DI
00616784511511
Brand
Gastrostomy Tube, 3 port, 20fr, ENFit
Company
DYNAREX CORPORATION
Model
5115
Published
2019-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PIFGastrointestinal Tubes With Enteral Specific Connectors

Product Code Classifications

CodeDeviceSpecialtyClass
PIFGastrointestinal Tubes With Enteral Specific ConnectorsGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784511535PackageGS15In Commercial Distribution
00616784511542PackageGS110In Commercial Distribution
00616784511511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784511535006167845115356167845115350616784511535
00616784511542006167845115426167845115420616784511542
00616784511511006167845115116167845115110616784511511

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810180843331Durma+ DynaRule Disposable Paper Rulers30062026-03-24
00810180845106Cotton Tipped Wood Applicators, Sterile43042022-04-22
00810180845113Cotton Tipped Wood Applicators, Sterile43052022-04-22
00810180840712CurPro Dermal Curettes,2 mm 41552024-12-16
00840117347892Medi-Cut Safety Scalpel41652022-04-17
00810180844901Disposable Prep Razors42512020-11-02
00810180844918Medicine Cups 1oz 42522024-10-28
00810180844925LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal 42542021-06-21
00810180844703Bandage Shears 7.5" Orange4183-BX2020-11-08
00810180844710Bandage Shears 7.5" Purple4184-BX2020-11-08
00810180844840Emesis Basin42242022-05-02
00810180844857Sitz Bath42282021-09-01
00810180844864Urinal- Male42292021-09-01
00810180844871Bed Pans42302021-04-22
00810180844888Bed Pans42312021-04-22
00810180844895Nuns Cap Specimen Collector42322021-04-22
00840117331822DynaSafety Heavy Duty Woven Fabric Knuckle Bandages, 1 1/2" x 3"3765BULK2024-03-08
00840117331853DynaSafety Heavy Duty Woven Fabric Bandages, Large Patch, 2" x 3"3766BULK2024-03-08
00840117331907DynaSafety Heavy Duty Woven Fabric Bandages, Sterile, 7/8" x 3"3767BULK2024-03-08
00840117350045Pill Crusher Pouch42102021-09-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00842071153038AMT MiniONE Extension SetAPPLIED MEDICAL TECHNOLOGY, INC.PIF2026-03-23
50192253012505Salem SumpCardinal Health 200, LLCPIF2026-03-19
50192253012987Salem SumpCardinal Health 200, LLCPIF2026-03-19
50192253068786CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068793CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068816CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068823CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253068830CARDINAL HEALTHCardinal Health 200, LLCPIF2026-02-25
50192253011447CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011461CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011515CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011553CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011577CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
50192253011614CARDINAL HEALTHCardinal Health 200, LLCPIF2025-12-19
05060999351571EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
05060999351601EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
05060999351632EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
05060999351670EnteralGBUK ENTERAL LIMITEDPIF2025-08-20
20813939024917VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024924VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024931VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024948VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024955VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
20813939024962VESCOXERIDIEM MEDICAL DEVICES, INC.PIF2025-06-16
00850016172488KBMEDKB Medical (group), Inc.PIF2025-05-21
00850016172495KBMEDKB Medical (group), Inc.PIF2025-05-21
50192253007570ArgyleCardinal Health 200, LLCPIF2025-04-24
50192253007594ArgyleCardinal Health 200, LLCPIF2025-04-24
50192253007617ArgyleCardinal Health 200, LLCPIF2025-04-24
50192253007631ArgyleCardinal Health 200, LLCPIF2025-04-24