SOL-M™ Blunt Fill Needle with 5 Micron Filter

GUDID 20818392015298

Used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. systems and pre-slit septums covering injection sites.

SOL-MILLENNIUM MEDICAL INC

Medicine preparation needle/cannula, sterile
Primary Device ID20818392015298
NIH Device Record Keyeed731bc-4a14-4ce3-8fb8-5f16f59fb312
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOL-M™ Blunt Fill Needle with 5 Micron Filter
Version Model Number110022
Company DUNS069590113
Company NameSOL-MILLENNIUM MEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com
Phone+1(404)973-2200
EmailSOLMCHUinform@sol-m.com

Device Dimensions

Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter
Needle Gauge18 Gauge
Length40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100818392015294 [Primary]
GS110818392015291 [Package]
Contains: 00818392015294
Package: Box [100 Units]
In Commercial Distribution
GS120818392015298 [Package]
Contains: 10818392015291
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LHISet, i.V. Fluid transfer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

Devices Manufactured by SOL-MILLENNIUM MEDICAL INC

00840368517099 - TYPENEX 2024-05-20 INTRODUCER SET
00840368516542 - TYPENEX 2024-04-23 INTRODUCER SET
00840368514326 - TYPENEX 2024-01-12 INTRODUCER SET
00840368514364 - TYPENEX 2024-01-12 INTRODUCER SET
20818392014666 - SOL-CARE Safety Multi-Sample Needle 2019-10-24 SOL-CARE Safety Multi-Sample Needle 21G*1 1/4
20818392014680 - SOL-CARE Safety Multi-Sample Needle 2019-10-24 SOL-CARE Safety Multi-Sample Needle 22G*1 1/4
20818392014956 - SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder 2019-10-24 SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder 21G*1 1/4
20818392014970 - SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder 2019-10-24 SOL-CARE Safety Multi-Sample Needle with Pre-attached Holder 22G*1 1/4

Trademark Results [SOL-M]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOL-M
SOL-M
98235765 not registered Live/Pending
Sol-Millennium Medical HK Limited
2023-10-23
SOL-M
SOL-M
85519145 4415447 Live/Registered
SOL-MILLENNIUM MEDICAL HK LIMITED
2012-01-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.