FDA.reportPublic FDA data

SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2

Primary DI
00818392019018
Brand
SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2
Company
Sol-Millennium Medical, Inc.
Model
32115SN
Published
2025-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen
MEGSyringe, Antistick

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241821000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241821000Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill NeedleSol-Millennium Medical, Inc.2024-09-20FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818392019015PackageGS150In Commercial Distribution
20818392019012PackageGS1300In Commercial Distribution
00818392019018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081839201901510818392019015
2081839201901220818392019012
00818392019018008183920190188183920190180818392019018

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA 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 needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It 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.

Contacts#

Phone, Email table
PhoneEmail
833-637-0857info@solm.com

Regulatory Flags#

DUNS number
069590113
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810018097462SOL-M Slip Tip Syringe 5 ml without needleP180005ST2025-03-30
00810018097493SOL-M 3ml Slip Tip Syringe w/o NeedleP180003ST2025-03-30
00810018097523SOL-M 1ml Slip Tip Syringe w/o NeedleP1800112025-03-30
00810018097646SOL-M Slip Tip Syringe 10 ml without needleP180010ST2025-03-30
00810018098551SOL-M 10ml Eccentric Tip Syringe w/o NeedleP180010ET2025-04-03
00810018098636SOL-M 20ml Slip Tip Syringe w/o NeedleP180020ST2025-03-30
00810018098698SOL-M 60ml Eccentric Tip Syringe w/o NeedleP180060ET2025-04-22
00810018098957SOL-M 1ml Slip Tip Syringe Sterile Convenience TrayP180011T2025-03-30
00810062435333SOL-M 30ml Slip Tip Syringe w/o Needle P180030ST2025-04-21
00810062435340SOL-M 60ml Slip Tip Syringe w/o NeedleP180060ST2025-04-21
00818392010657SOL-M™ Hypodermic Needle1126382016-09-16
00818392010664SOL-M™ Hypodermic Needle1126122016-09-16
00818392010671SOL-M™ Hypodermic Needle1126582017-10-23
00818392010701SOL-M™ Hypodermic Needle1118102017-10-23
00818392011074SOL-CARE™ Insulin Safety Syringe with Fixed Needle100020IM2016-09-16
00818392012378SOL-M™ Hypodermic Needle11221252016-09-16
00818392012385SOL-M™ Hypodermic Needle1127342016-09-16
00818392012743SOL-M™ Hypodermic Needle1119152016-09-16
00818392012750SOL-M™ Hypodermic Needle1131122017-10-23
00818392012828SOL-M™ Hypodermic Needle1124102016-09-16

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
00850091070433CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070433CoreCareCORECARE 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