FDA.reportPublic FDA data

NC601000

Primary DI
10816336022084
Brand
NC601000
Company
NEOCHILD, LLC
Model
NC601000
Device description
Enteral Only 10ml Syringe with Oral Cap
Published
2019-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103830000JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)Jiangsu Shenli Medical Production Factory2011-07-29FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20816336022081PackageGS1100In Commercial Distribution
30816336022088PackageGS1100In Commercial Distribution
10816336022084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081633602208120816336022081
3081633602208830816336022088
1081633602208410816336022084

GMDN Terms#

Term, Definition table
TermDefinition
Syringe-accepting percutaneous/submucosal fluid injector, manual, professionalA hand-held, manually-powered mechanical device intended for use by a healthcare professional to accept a syringe (not included) for administering a percutaneous (e.g., intramuscular, subcutaneous) and/or submucosal injection of a medical fluid (e.g., medication, vaccine) to a patient; it is not dedicated to dental or intravenous applications. The device is typically a spring-loaded mechanical assembly in the form of a pistol or cylinder; the pharmaceutical is not included. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
022760922
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10816336022671NC603500-ENFNC603500-ENF2026-09-10
10816336022053NC600100NC6001002019-03-01
10816336022060NC600300NC6003002019-03-01
10816336022077NC600500NC6005002019-03-01
10816336022091NC602000NC6020002019-03-01
10816336022107NC603000NC6030002019-03-01
10816336022114NC606000NC6060002019-03-01
10816336022138NC600100FNC600100F2019-03-20
10816336022145NC600300FNC600300F2019-03-20
10816336022152NC600500FNC600500F2019-03-20
10816336022169NC601000FNC601000F2019-03-20
10816336022176NC602000FNC602000F2019-03-20
10816336022183NC603000FNC603000F2019-03-20
10816336022190NC606000FNC606000F2019-03-20
10816336022206NC600500-ENFNC600500-ENF2023-12-19
10816336022213NC600600NC6006002021-08-18
10816336022220NC601200NC6012002021-08-18
10816336022237NC603500NC6035002021-08-18
10816336022459NC603000-ENFNC603000-ENF2023-12-19
10816336022787NC601000-ENFNC601000-ENF2023-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934841531291TKMDAnhui Tiankang Medical Technology Co., Ltd.FMF2026-10-23
MHC182332552EasyTouchMHC MEDICAL PRODUCTS, LLCFMF2026-10-21
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193867Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193874Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193881Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193898Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194109Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194116Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194208Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194215Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194222Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
00850091070532CoreCareCorecare Products Inc.FMF2026-09-11
00850091070556CoreCareCorecare Products Inc.FMF2026-09-11
00850091070570CoreCareCorecare Products Inc.FMF2026-09-11
00850091070594CoreCareCorecare Products Inc.FMF2026-09-11
00850091070617CoreCareCorecare Products Inc.FMF2026-09-11
00850091070631CoreCareCorecare Products Inc.FMF2026-09-11
00850091070655CoreCareCorecare Products Inc.FMF2026-09-11
00850091070679CoreCareCorecare Products Inc.FMF2026-09-11
10816336022671NC603500-ENFNEOCHILD, LLCFMF2026-09-10
00850091070242CoreCareCorecare Products Inc.FMF2026-09-04