FDA.reportPublic FDA data

IS60EN

Primary DI
10816336020035
Brand
IS60EN
Company
NEOCHILD, LLC
Model
IS60EN
Device description
"Enteral Tubing Extension 60"""
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082710000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082710000SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SETNeochild, LLC2009-01-23KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816336020660PackageGS150In Commercial Distribution
10816336020035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081633602066010816336020660
1081633602003510816336020035

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding kit, infantA collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an infant patient by means of gravity or an enteral pump. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(888)887-6428info@neochild.com

Regulatory Flags#

DUNS number
022760922
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816336022275NC600300-ENFNC600300-ENF2026-07-23
10816336022282NC602000-ENFNC602000-ENF2026-07-23
10816336022442NC600100-ENFNC600100-ENF2026-07-23
00108163360204NeoChildNeoChildNC2000022025-03-04
20816336020346NC200002NC2000022025-05-08
20816336020353NC200002NC2000022025-05-08
20816336020858NeoChildNeoChildNC2000022025-03-04
10816336020004IS60ENOCIS60ENOC2024-06-12
10816336020301NC40100TNC40100T2018-02-19
10816336022121NC70000TNC70000T2019-03-01
10816336020936NC40100TNC40100T2018-02-19
10816336020318NC40150TNC40150T2018-02-19
10816336020998KMI-UACTRAYHKMI-UACTRAYH2024-07-15
20816336020971KMI-UACTRAYHKMI-UACTRAYH2024-07-15
02081633602005IS60ENOCIS60ENOC2024-06-12
10816336022732NC23000TNC23000T2024-03-24
20816336022739NC23000TNC23000T2024-03-24
10816336022381NC1P65SE-ENFNC1P65SE-ENF2024-01-11
20816336022388NC1P65SE-ENFNC1P65SE-ENF2024-01-11
10816336022206NC600500-ENFNC600500-ENF2023-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G461CEGCT40M0EndolumikEndolumik, Inc.KNT2026-08-25
00350770006840CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770009094CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770007557CORFLO* Safety PEG KitAvanos Medical, Inc.KNT2026-08-14
00842071146436MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071146443MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071153083NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
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
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
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
00860007229428QoraCM TECHNOLOGIES, INC.KNT2025-03-12
G461EGCT36M0EndolumikEndolumik, Inc.KNT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
08015262022259VYGONVygon CorporationKNT2024-05-08
10192253007565ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007589ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007602ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007626ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007640ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007763ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007800KangarooCardinal Health 200, LLCKNT2024-04-12