FDA.reportPublic FDA data

CORTRAK® 2 + CORGRIPTM Combo Pak

Primary DI
10815149021901
Brand
CORTRAK® 2 + CORGRIPTM Combo Pak
Company
CORPAK MEDSYSTEMS, INC.
Model
45-9361TRAK-PAK
Catalog number
45-9361TRAK-PAK
Device description
CORTRAK feeding tube and CORGRIP tube retention system, with ENFit Connectors
Published
2016-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
20815149021908PackageGS15In Commercial Distribution
10815149021901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081514902190820815149021908
1081514902190110815149021901

GMDN Terms#

Term, Definition table
TermDefinition
Enteral tube tracking system transmitter styletA non-sterile, thin, flexible wire with an electromagnetic (EM) transmitter at the distal end that is a component of an enteral tube tracking system and intended to be used as a stylet for an enteral feeding tube with which it is supplied. It is designed to facilitate the placement of the enteral tube by providing a signal used to create a graphic display representing the path of the tube tip. During use it is typically connected to a visual display/control unit and is used with an electromagnetic transmission receiver placed on the epigastrium. This is a reusable device intended for single-patient use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Device Size Text, specify0
Length36Inch

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
147530323
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842071153106NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153120NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01
00816340021649EL-SPIKE-FNEODEVICES INCKNT2026-06-01
00816340021656EL-S55-HFNEODEVICES INCKNT2026-06-01
10192253011210KangarooCardinal Health 200, LLCKNT2026-04-17
10192253006834Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006841Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006858Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253011449CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011555CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
10192253011128KangarooCardinal Health 200, LLCKNT2025-05-28
10192253011159CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011173CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011197CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011227CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011258CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011272CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011296CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011104KangarooCardinal Health 200, LLCKNT2025-01-14
G461EGCT36M0EndolumikEndolumik, Inc.KNT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
10192253011319KangarooCardinal Health 200, LLCKNT2024-06-13