FDA.reportPublic FDA data

CORTRAK* Enteral Access System

Primary DI
00350770456409
Brand
CORTRAK* Enteral Access System
Company
Avanos Medical, Inc.
Model
20-0930
Catalog number
20-0930
Device description
Smart Receiver Plastic Cover
Published
2020-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00350770456409PrimaryGS10
10350770456406Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00350770456409003507704564093507704564090350770456409
1035077045640610350770456406

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
100
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01
00609038351193AVANOS35119351192020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10192253011579CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011593CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011616CARDINAL 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
10192253011630CARDINAL 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
10192253011326KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011333KangarooCardinal Health 200, LLCKNT2024-06-13