From:
Lisa Ramirez <ardchemlmr**At_Symbol_Here**GMAIL.COM>
Subject:
Re: [DCHAS-L] Filtration syringes
Date:
Jan 6, 2025 20:04 UTC
Reply-To:
ACS Division of Chemical Health and Safety <DCHAS-L**At_Symbol_Here**Princeton.EDU>
Message-ID:
<CAP5FG3ZsMWvhoJs_OuKD9-c8HFRkc7q2HAO4CcVqmmDZyZcKxQ**At_Symbol_Here**mail.gmail.com>
In-Reply-To:
<LV8PR13MB6559D5F3D2E2A99A719EA45AB9142**At_Symbol_Here**LV8PR13MB6559.namprd13.prod.outlook.com>
Hello,
AIR-TITE is a company that also supplies syringes. They are for laboratory use as well as veterinary use. The syringes are a luer-lok style so filters will easily attach.
Sincerely,
Lisa M Ramirez
Senior Chemist
OCWD
Our company purchases and sells filtration syringes for use with analytical test methods. Recently, our supplier of more than a decade denied our request to purchase, stating that the syringe was deemed by the manufacturer (BD) as a Prescription
Medical Device.
We have been asked to provide regulatory evidence for sale, including exemption from Medical/Pharmaceutical licensure. I have searched Federal code, and the closest thing I found was 21 CFR 801.125. However, additional restrictions appear
to be State dependent (we are in Maryland). Has anyone experienced this with filtration syringes before? Were you able to identify the exemption statute?
Any suggestions for alternatives to BD syringes? Must be filtration disc compatible (screw tip) and NOT labeled for medical use.
Greatly appreciate your help!
Janine Rhodes
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