Data / Medical devices / United States / Aero-Med LLC

Aero-Med LLC: FDA-registered device maker in East Hartford, CT, United States, 5 510(k) clearances

Name: Aero-Med LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Aero-Med LLC is registered with the FDA (registration 3006191977) in East Hartford, CT, United States. It lists 24 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 28, 1998. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006191977
Address: 65 Olde Roberts St, East Hartford, CT, United States, 06108
Owner or operator: Cardinal Health 200, LLC (9028292)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: August 19, 1992
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Aspiration Tray	OJT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Blood And Urine Collection Kit (Excludes Hiv Testing)	OIB	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Blood Borne Pathogen Response Kit	PWP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Blood Specimen Collection Convenience Kit (Excludes Hiv)	PQD	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bone Marrow Biopsy Tray	PXO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bone Marrow Collection/Transfusion Kit	LWE	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Non-Sterile	NNK	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Sterile	KDT	1	Repackager or relabeler	accessdata.fda.gov
Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile	NNL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Container, Specimen, Non-Sterile	NNI	1	Repackager or relabeler	accessdata.fda.gov
Cytology Kit	OKY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gastro-Urology Biopsy Kit	PRV	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
General Surgery Tray	LRO	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
I.V. Start Kit	LRS	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Repackager or relabeler	accessdata.fda.gov
Micro Pipette	JRC	1	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Repackager or relabeler	accessdata.fda.gov
Oxygen Administration Kit	OGL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Pap Smear Kit	OHL	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Spatula, Cervical, Cytological	HHT	2	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical	LRP	1	Repackager or relabeler	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 28, 1998	K983952	GREINER VACUETTE BLOOD COLLECTION TUBE	JKA	Substantially Equivalent	Greiner Meditech, Inc.	accessdata.fda.gov
July 24, 1997	K971849	CYTOLOGY BRUSH	HHT	Substantially Equivalent	Team Technologies, Inc.	accessdata.fda.gov
January 18, 1995	K945952	VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE	JKA	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic	accessdata.fda.gov
May 24, 1994	K930955	CERVEX-BRUSH	HHT	Substantially Equivalent	Rovers B.V.	accessdata.fda.gov
January 4, 1990	K896065	WALLACH CC/BRUSH	HHT	Substantially Equivalent	Wallach Surgical Devices, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 28, 1998. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.