FDA.reportPublic FDA data

IS6018

Primary DI
10816336020523
Brand
IS6018
Company
NEOCHILD, LLC
Model
IS6018
Device description
Minibore Extension Set 60 inch. 1.8 mL priming vol
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
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003854000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003854000INTRAVASCULAR ADMINISTRATION SETInfusion Devices, Inc.2001-02-05FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816336021155PackageGS150In Commercial Distribution
10816336020523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081633602115510816336021155
1081633602052310816336020523

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. 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
04046955765164IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-27
00884450707104Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
00884450707111Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)Dynarex CorporationFPA2026-06-30
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23