FDA.reportPublic FDA data

CORFLO Jejunal Tube

Primary DI
20815149020741
Brand
CORFLO Jejunal Tube
Company
CORPAK MEDSYSTEMS, INC.
Model
50-1438
Catalog number
50-1438
Device description
Jejunal tube with ENFit connectors over the wire for use with CORFLO PEG
Published
2016-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20815149020741PackageGS12In Commercial Distribution
10815149020744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081514902074120815149020741
1081514902074410815149020744

GMDN Terms#

Term, Definition table
TermDefinition
Jejunostomy tubeA sterile, thin, flexible, hollow tube percutaneously inserted into the jejunum, typically through puncture of the abdominal wall and stomach after distention of the gut by endoscopic methods. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and/or to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length43Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(847)403-3400questions@corpak.com

Regulatory Flags#

DUNS number
147530323
Device count
1
DM exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815149021147CORGRIP Tube Retention System25-00825-0082016-08-04
10815149021154CORGRIP Tube Retention System25-01025-0102016-08-04
10815149021161CORGRIP Tube Retention System25-01225-0122016-08-04
10815149025442CORGRIP Tube Retention System25-01425-0142017-02-27
10815149025459CORGRIP Tube Retention System25-01625-0162017-02-27
10815149025466CORGRIP Tube Retention System25-01825-0182017-02-27
10815149021734CORFLO Y Extension Set40-100740-10072016-07-28
10815149022861CORFLO cuBBy Decompression Set56-011256-01122016-06-24
10815149022878CORFLO cuBBy Right Angle Feeding Set56-901256-90122016-06-24
10815149022885CORFLO cuBBy Right Angle Feeding Set56-902456-90242016-06-24
10815149024445CORFLO cuBBy35-901235-90122016-08-04
10815149024452CORFLO cuBBy35-902435-90242016-08-04
10815149024469Enteral Y Extension Set20-100720-10072016-08-04
10815149024711CORFLO AIV Enteral Feeding Extension Set20-1030AIV20-1030AIV2016-08-04
10815149024728CORFLO AIV Enteral Feeding Tube Extension Set20-1060AIV20-1060AIV2016-08-04
10815149024735CORFLO AIV Enteral Feeding Extension Set20-1060AIV-S20-1060AIV-S2016-08-04
10815149025268Mapcath stylet60-201160-20112016-08-04
10815149025275Mapcath stylet60-201860-20182016-08-04
20815149021144CORGRIP Tube Retention System25-00825-0082016-08-04
20815149021151CORGRIP Tube Retention System25-01025-0102016-08-04

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