FDA.reportPublic FDA data

SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8

Primary DI
00810062435319
Brand
SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8
Company
Sol-Millennium Medical, Inc.
Model
12558LDS
Published
2025-04-21
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
QNQLow Dead Space Piston Syringe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNQLow Dead Space Piston SyringeGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242291000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242291000SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable NeedleSol-Millennium Medical, Inc.2024-11-20QNQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810062435316PackageGS150In Commercial Distribution
20810062435313PackageGS1300In Commercial Distribution
00810062435319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081006243531610810062435316
2081006243531320810062435313
00810062435319008100624353198100624353190810062435319

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
06958697621449LDV (Low Dead Volume) Syringe ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDQNQ2026-03-25
06958697621456LDV (Low Dead Volume) SyringeANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDQNQ2026-03-25
06958697621463LDV (Low Dead Volume) SyringeANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDQNQ2026-03-25
15056093011227SJJPROSUM MEDICAL LIMITEDQNQ2026-01-21
10810062435316SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8Sol-Millennium Medical, Inc.QNQ2025-04-21
00818392019407SOL-M 1ml Slip Tip Syringe w/o needle (low dead space)Sol-Millennium Medical, Inc.QNQ2025-04-01
10818392019404SOL-M 1ml Slip Tip Syringe w/o needle (low dead space)Sol-Millennium Medical, Inc.QNQ2025-04-01
00810018097554SOL-M Slip Tip Syringe 1 ml without needle (LDS)Sol-Millennium Medical, Inc.QNQ2025-03-30
08800145513760LDV Syringe 1mL/cc x 1FTIFDN7 (30G x 5/16)Feeltech Co.,Ltd.QNQ2024-12-10
08800145513791LDV Syringe 1mL/cc x 1FT x FDN3 (23G x 25mm)Feeltech Co.,Ltd.QNQ2024-12-10
08800145513807LDV Syringe 1mL/cc x 1FT x FDN24 (25G x 25.4mm)Feeltech Co.,Ltd.QNQ2024-12-10
08800145513814LDV Syringe 1mL/cc x 1FT x FDN37 (25G x 38.1mm)Feeltech Co.,Ltd.QNQ2024-12-10
08800145513821LDV Syringe 1mL/cc x 1FT x FDN38 (23G x 38.1mm)Feeltech Co.,Ltd.QNQ2024-12-10
00818392018165SOL-M SyringeSol-Millennium Medical, Inc.QNQ2019-04-12