FDA.reportPublic FDA data

CoreCare

Primary DI
00850091070280
Brand
CoreCare
Company
CORECARE PRODUCTS INC.
Model
Insulin Syringe, double cap 0.3ml, 31GX5/16''
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202570000Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd.2021-07-02MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850091070280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850091070280008500910702808500910702800850091070280

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. 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
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
00850091070433CoreCare3ml Luer-Lock Syringes W/Needle, 25GX1''2026-09-04

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
00850091070259CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070266CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070273CoreCareCORECARE 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
00850091070433CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
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