FDA.reportPublic FDA data

CoreCare

Primary DI
00850091070334
Brand
CoreCare
Company
CORECARE PRODUCTS INC.
Model
Disposable needle, 27Gx1 1/2'' (One and half inch)
Published
2026-09-04
Public version status
New
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
00850091070334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850091070334008500910703348500910703340850091070334

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
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850091070013CoreCareInsulin Syringe, double cap, 0.5ml, 30GX5/16''2026-09-04
00850091070235CoreCareInsulin Syringe, double cap 0.5ml, 31GX5/16''2026-09-04
00850091070242CoreCare3ml Luer-Lock Syringes W/Needle, 23GX1''2026-09-04
00850091070259CoreCareInsulin Syringe, double cap, 1ml,30GX5/16''2026-09-04
00850091070266CoreCareInsulin Syringe, double cap, 0.3ml, 30GX5/16''2026-09-04
00850091070273CoreCareInsulin Syringe, double cap 1ml, 31GX5/16''2026-09-04
00850091070280CoreCareInsulin Syringe, double cap 0.3ml, 31GX5/16''2026-09-04
00850091070297CoreCareDisposable needle, 18GX1''2026-09-04
00850091070303CoreCareDisposable needle, 25GX1''2026-09-04
00850091070310CoreCareDisposable needle, 22GX1 1/2''(One and half inch)2026-09-04
00850091070327CoreCareDisposable needle, 26GX5/8''2026-09-04
00850091070341CoreCareDisposable needle,30GX1''2026-09-04
00850091070365CoreCareDisposable needle,30GX1/2''2026-09-04
00850091070372CoreCare3ml Luer-Lock Syringes W/O Needle2026-09-04
00850091070389CoreCare1ml Luer-Lock Syringes W/O Needle2026-09-04
00850091070396CoreCare5ml Luer-Lock Syringes W/O Needle2026-09-04
00850091070402CoreCare10 ml Luer-Lock Syringes W/O Needle2026-09-04
00850091070419CoreCare30ml Luer-Lock Syringes W/O Needle2026-09-04
00850091070426CoreCare60ml Luer-Lock Syringes W/O Needle2026-09-04
00850091070433CoreCare3ml Luer-Lock Syringes W/Needle, 25GX1''2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070259CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070266CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070273CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070280CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070297CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070303CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070310CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070327CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070341CoreCareCORECARE PRODUCTS INC.FMI2026-09-04