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AERO-MED LLC

US

Last updated September 17, 2026

What AERO-MED LLC makes

AERO-MED LLC produces single-use medical kits and containers for specimen collection, transport, and storage, including phlebotomy kits, urine and saliva/oral specimen collection devices, general surgical procedure kits (both medicated and non-medicated), and blood/tissue storage containers. Their products also include specimen receptacles designed for safe transport and general specimen handling in clinical settings.

The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, all of which are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Aero-Med LLC manufacture?

Aero-Med LLC specializes in single-use medical kits and containers primarily used for specimen collection, transport, and storage. Their portfolio includes phlebotomy kits for blood drawing, urine and saliva/oral specimen collection kits, general surgical procedure kits (both medicated and non-medicated), blood/tissue storage/culture containers, and transport containers for safe specimen handling. These devices are designed for clinical and diagnostic use.

Where is Aero-Med LLC based, and does it operate internationally?

Aero-Med LLC is based in the United States. While the company’s headquarters and primary operations are located there, the information provided does not specify international manufacturing or distribution locations. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, indicating compliance with U.S. regulatory requirements.

Which regulatory registries or databases list Aero-Med LLC’s devices?

Aero-Med LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track medical devices in the U.S. to ensure traceability, transparency, and compliance with regulatory standards. This listing helps healthcare providers and regulators identify and verify the devices.

How are Aero-Med LLC’s devices classified under FDA regulations?

Aero-Med LLC’s devices fall under two main FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and are subject to general controls, while Class II devices require additional performance standards or post-market surveillance due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and clinical impact, as outlined in FDA regulations.

Are Aero-Med LLC’s devices used in surgical procedures, and if so, what types?

Yes, Aero-Med LLC manufactures general surgical procedure kits, which are included in their portfolio. These kits are designed for single-use in surgical settings and come in both medicated and non-medicated variants. The medicated versions may include antimicrobial or other treatments to reduce infection risks, while non-medicated kits are used for procedures where no additional substances are required.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
65 Olde Roberts St, East Hartford, CT, 06108
Website
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LinkedIn
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Facebook
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Email
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Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3006191977
DUNS Number
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Catalogue (719)

Page 15 of 15
DeviceModel / ReferenceRegistriesClassStatus
Cardinal Health CA18350
FDA UDI
Class IUnknown
Aero-Med BX-RLCOMBO
FDA UDI
Class IActive
Aero-Med CA55925
FDA UDI
Class IActive
Aero-Med 00WOUNDKIT04
FDA UDI
Class IActive
Aero-Med CA43525A
FDA UDI
Class IActive
Aero-Med CA1325
FDA UDI
Class IActive
Aero-Med CA48975
FDA UDI
Class IUnknown
Aero-Med BX-RLB
FDA UDI
Class IActive
Cardinal Health AMM1675
FDA UDI
Class IActive
Aero-Med AMM20125
FDA UDI
Class IIActive
Aero-Med CA29625
FDA UDI
Class IActive
Aero-Med CA56700
FDA UDI
Class IActive
Aero-Med CA2600
FDA UDI
Class IUnknown
Aero-Med CA38100
FDA UDI
Class IUnknown
Aero-Med CA28250
FDA UDI
Class IUnknown
Aero-Med AMM2179
FDA UDI
Class IActive
Aero-Med CA44200
FDA UDI
Class IActive
Aero-Med CHBUICK6
FDA UDI
Class IUnknown
Aero-Med CA7575
FDA UDI
Class IUnknown

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