FDA.reportPublic FDA data

CoreCare

Primary DI
00850091070433
Brand
CoreCare
Company
CORECARE PRODUCTS INC.
Model
3ml Luer-Lock Syringes W/Needle, 25GX1''
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
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850091070433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850091070433008500910704338500910704330850091070433

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. 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
00850091070334CoreCareDisposable needle, 27Gx1 1/2'' (One and half inch)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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
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
00850091070334CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070341CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070365CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070372CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070389CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070396CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070402CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070419CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070426CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00814965020481Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020504Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020528Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020542Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020788Precision PointGold Coast Medical Supply, LPFMI2026-08-26
06976523540238Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540252Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06972857295677contour comfort Pen NeedleSandstone Medical (Suzhou) Inc.FMI2026-08-19