FDA.reportPublic FDA data

IS6003-MSC

Primary DI
10816336022268
Brand
IS6003-MSC
Company
NEOCHILD, LLC
Model
IS6003-MSC
Device description
Microbore Extension Set 60”, 0.3 priming volume with Marvelous Stopcock
Published
2022-09-09
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
20816336022265PackageGS150In Commercial Distribution
10816336022268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081633602226520816336022265
1081633602226810816336022268

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.

Sterilization Methods#

Method table
Method

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