Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006191977

FEI Number

3006191977

Entity Name

AERO-MED LLC

City/State/Country

East Hartford, CT, US

Establishment Address

65 Olde Roberts St, East Hartford, CT 06108, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Cardinal Health 200, LLC (Owner Number: 9028292)

Owner / Operator Contact Address

3651 Birchwood Drive, --, Waukegan, IL 60085, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2006-05-18
OIB	Blood And Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2011-11-09
PJE	Blood/Plasma Collection Device For Dna Testing	Clinical Chemistry	Class 2	862.1675	2025-02-18
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2020-10-07
OGL	Oxygen Administration Kit	Anesthesiology	Class 2	868.5655	2011-11-09
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2005-04-13
LWE	Bone Marrow Collection/Transfusion Kit	Unknown	Class 2	N/A	2011-11-11
PWP	Blood Borne Pathogen Response Kit	General Hospital	Class 1	880.6250	2026-03-05
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2009-06-25
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2019-01-14
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2007-04-26
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	1996-05-01
JXA	Kit, Screening, Urine	Microbiology	Class 1	866.2660	2014-10-28
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2009-05-06
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2019-03-13
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	1993-02-05
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2014-10-28
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2019-03-13
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2018-06-05
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2019-01-15
OKY	Cytology Kit	Obstetrics/Gynecology	Class 2	884.4530	2011-11-14
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2019-03-13
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2019-01-14
OIA	Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2011-11-09
LEA	Preservative, Cytological	Pathology	Class 1	864.4010	2015-11-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cardinal Health 200, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004839227	Cardinal Health Malta 212 Ltd	Marsa, MT
3015541720	Cardinal Health Germany Manufacturing GmbH	Halberstadt Saxony-Anhalt, DE
1033903	Cardinal Health	Greenwood, SC, US
9611018	Cardinal Health Ireland Manufacturing Limited	TULLAMORE Offaly, IE
8040459	Kendall-Gammatron Limited	SAMPRAN Nakhon Pathom, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K963801	Young OU Brush Co.	PAP BRUSH	1997-04-09
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

Similar Registrations

Registration Number	Establishment Name	Location
3002669946	Owens & Minor Distribution Inc. OM45	Sunrise, FL, US
1646747	WEXLER SURGICAL, INC.	HOUSTON, TX, US
1037577	ANGIOSYSTEMS, INC.	DUCKTOWN, TN, US
3016171961	HANGZHOU ALLINE PLASTIC CO., LTD.	HANGZHOU Zhejiang, CN
3007485169	MEDYSSEY CO., LTD.	Jecheon-si Chungbuk, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006191977. Last updated year: 2026. Please use registration number 3006191977 when referencing this establishment in official correspondence.