FDA.reportPublic FDA data

CoreCare

Primary DI
00850091070495
Brand
CoreCare
Company
Corecare Products Inc.
Model
Disposable needle, 30GX1''
Device description
Disposable needle, 30GX1''
Published
2026-09-11
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

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850091070501PackageGS1100In Commercial Distribution
00850091070495PrimaryGS10
10850091070492Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850091070501008500910705018500910705010850091070501
00850091070495008500910704958500910704950850091070495
1085009107049210850091070492

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Regulatory Flags#

DUNS number
134870424
Device count
100
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
true
Expiration date on label
true
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
00850091070006CoreCareExam Table Paper 21" 'x 225'2026-09-08
00850091070020CoreCareExam Table Paper 18" x 225'2026-09-08
00850091070037CoreCareInsulin Syringe, double cap, 0.3ml, 30GX5/16'2026-09-11
00850091070051CoreCareInsulin Syringe, double cap, 1ml,30GX5/2026-09-11
00850091070068CoreCareInsulin Syringe, double cap, 0.5ml, 30GX5/16'2026-09-11
00850091070099CoreCareInsulin Syringe, double cap 1ml, 31GX5/16''2026-09-11
00850091070112CoreCareInsulin Syringe, double cap 0.5ml, 31GX5/162026-09-11
00850091070136CoreCareInsulin Syringe, double cap 0.3ml, 31GX5/12026-09-11
00850091070150CoreCareDisposable needle, 18GX1''2026-09-11
00850091070174CoreCareDisposable needle, 25GX1''2026-09-11
00850091070198CoreCareDisposable needle, 22GX1 1/2''(One and half inch2026-09-11
00850091070228CoreCareDisposable needle, 26GX5/8''2026-09-11
00850091070440CoreCareAlcohol Wipe 30x60mm2026-09-08
00850091070457CoreCareAlcohol Wipe 60x60mm2026-09-08
00850091070471CoreCareDisposable needle, 27Gx1 1/2'' (One and half inc2026-09-11
00850091070518CoreCareDisposable needle, 30GX1/2''2026-09-11
00850091070532CoreCare3ml Luer-Lock Syringes W/O Needle2026-09-11
00850091070556CoreCare1ml Luer-Lock Syringes W/O Needle2026-09-11
00850091070570CoreCare5ml Luer-Lock Syringes W/O Needle2026-09-11
00850091070594CoreCare10 ml Luer-Lock Syringes W/O Needle2026-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20357515755043UltiCareULTIMED, INC.FMI2026-10-23
16972857299337Pen Needles ClassicSandstone Medical (Suzhou) Inc.FMI2026-10-11
16972857299290Easydrip Readygard DuoSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299306Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
06958697621821One+Step INSULIN PEN NEEDLEANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDFMI2026-10-01
M99230402912120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
M99230403250120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
00850002860733Comfort EZ Pro DuoS.D.I. USA, INC.FMI2026-09-28
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-09-24
MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
00850091070037CoreCareCorecare Products Inc.FMI2026-09-11
00850091070051CoreCareCorecare Products Inc.FMI2026-09-11
00850091070068CoreCareCorecare Products Inc.FMI2026-09-11
00850091070099CoreCareCorecare Products Inc.FMI2026-09-11
00850091070112CoreCareCorecare Products Inc.FMI2026-09-11
00850091070136CoreCareCorecare Products Inc.FMI2026-09-11
00850091070150CoreCareCorecare Products Inc.FMI2026-09-11
00850091070174CoreCareCorecare Products Inc.FMI2026-09-11
00850091070198CoreCareCorecare Products Inc.FMI2026-09-11
00850091070228CoreCareCorecare Products Inc.FMI2026-09-11
00850091070471CoreCareCorecare Products Inc.FMI2026-09-11