FDA.report

CORLO Twoomey

Primary DI
20815149024176
Brand
CORLO Twoomey
Company
CORPAK MEDSYSTEMS, INC.
Model
30-6216
Catalog number
30-6216
Device description
Corflo® Twoomey Y-Adaptor 16 FR
Published
2016-08-04
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

Related Records

Contact Domains

Product Codes

CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20815149024176PackageGS15In Commercial Distribution
10815149024179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2081514902417620815149024176
1081514902417910815149024179

GMDN Terms

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

TypeValueUnit
Catheter Gauge16French

Sterilization Methods

Method

Contacts

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 DIBrandModelCatalogPublished
20815149021144CORGRIP Tube Retention System25-00825-0082016-08-04
20815149021151CORGRIP Tube Retention System25-01025-0102016-08-04
20815149021168CORGRIP Tube Retention System25-01225-0122016-08-04
20815149021731CORFLO Y Extension Set40-100740-10072016-07-28
20815149022868CORFLO cuBBy Decompression Set56-011256-01122016-06-24
20815149022875CORFLO cuBBy Right Angle Feeding Set56-901256-90122016-06-24
20815149022882CORFLO cuBBy Right Angle Feeding Set56-902456-90242016-06-24
20815149024442CORFLO cuBBy35-901235-90122016-08-04
20815149024459CORFLO cuBBy35-902435-90242016-08-04
20815149024466Enteral Y Extension Set20-100720-10072016-08-04
20815149024718CORFLO AIV Enteral Feeding Extension Set20-1030AIV20-1030AIV2016-08-04
20815149024725CORFLO AIV Enteral Feeding Tube Extension Set20-1060AIV20-1060AIV2016-08-04
20815149024732CORFLO AIV Enteral Feeding Extension Set20-1060AIV-S20-1060AIV-S2016-08-04
20815149025265Mapcath stylet60-201160-20112016-08-04
20815149025272Mapcath stylet60-201860-20182016-08-04
10815149025442CORGRIP Tube Retention System25-01425-0142017-02-27
10815149025459CORGRIP Tube Retention System25-01625-0162017-02-27
10815149025466CORGRIP Tube Retention System25-01825-0182017-02-27
10815149025312Navigator60-300260-30022016-08-04
10815149025329Navigator Bionavigation System60-302060-30202016-08-04

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