DEVICE: SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle (00818392015904)

Device Identifier (DI) Information

SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle
100084IM
In Commercial Distribution

Sol-Millennium Medical, Inc.
00818392015904
GS1

1
069590113 *Terms of Use
Used to inject fluids into, or withdraw fluids from the body. In addition, the device is designed to aid in the prevention of needle stick injuries. SOL-CARE™ 3ml Luer Lock Safety Syringe w/ Exch Needle 20G*1 1/2
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
59230 Hypodermic needle, single-use
A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.
Active false
47017 General-purpose syringe, single-use
A 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.
Active false
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FDA Product Code

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Product Code Product Code Name
MEG SYRINGE, ANTISTICK
FMI Needle, Hypodermic, Single Lumen
FMF Syringe, Piston
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 3 Milliliter
Needle Gauge: 20 Gauge
Length: 40 Millimeter
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Device Record Status

440255d7-1294-4067-a41e-21da5cba057b
May 01, 2025
4
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10818392015901 100 00818392015904 In Commercial Distribution Box
20818392015908 8 10818392015901 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
833-637-0857
info@solm.com
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