FDA.reportPublic FDA data

SOL-M 1ml Slip Tip Syringe w/o needle (low dead space)

Primary DI
10818392019404
Brand
SOL-M 1ml Slip Tip Syringe w/o needle (low dead space)
Company
Sol-Millennium Medical, Inc.
Model
180011LDS
Published
2025-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10818392019404PackageGS1100In Commercial Distribution
00818392019407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081839201940410818392019404
00818392019407008183920194078183920194070818392019407

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
069590113
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810062435319SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8Sol-Millennium Medical, Inc.QNQ2025-04-21
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
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