FDA Registration
Active
🇺🇸 United States
AERO-MED LLC
Reg #: 3006191977
·
FEI: 3006191977
·
Expires 2026
Products
27
Proprietary Names
0
Establishment Types
3
Classifications
27
Registration Details
- Registration Name
- AERO-MED LLC
- Registration Number
- 3006191977
- FEI Number
- 3006191977
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 65 Olde Roberts St
- City
- East Hartford
- State
- CT
- ZIP
- 06108
- Country
- US
Regulatory Submissions
- 510(k) Number
- K012043
Owner / Operator
- Firm Name
- Cardinal Health 200, LLC
- Operator Number
- 9028292
- Address
- 3651 Birchwood Drive, --
- City
- Waukegan
- State
- IL
- Postal Code
- 60085
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2006-05-18 |
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | Class 1 | Pathology | No | 2011-11-09 |
| Blood/Plasma Collection Device For Dna Testing | PJE | Class 2 | Clinical Chemistry | No | 2025-02-18 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2020-10-07 |
| Oxygen Administration Kit | OGL | Class 2 | Anesthesiology | No | 2011-11-09 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2005-04-13 |
| Bone Marrow Collection/Transfusion Kit | LWE | Class 2 | Unknown | No | 2011-11-11 |
| Blood Borne Pathogen Response Kit | PWP | Class 1 | General Hospital | No | 2026-03-05 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2009-06-25 |
| Spatula, Cervical, Cytological | HHT | Class 2 | Obstetrics/Gynecology | No | 2019-01-14 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2007-04-26 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 1996-05-01 |
| Kit, Screening, Urine | JXA | Class 1 | Microbiology | No | 2014-10-28 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2009-05-06 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2019-03-13 |
| Arterial Blood Sampling Kit | CBT | Class 1 | Anesthesiology | No | 1993-02-05 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2014-10-28 |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2018-06-05 |
| Cytology Kit | OKY | Class 2 | Obstetrics/Gynecology | No | 2011-11-14 |
| Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing) | OIA | Class 1 | Pathology | No | 2011-11-09 |
| Preservative, Cytological | LEA | Class 1 | Pathology | No | 2015-11-11 |
| Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile | NNL | Class 1 | Pathology | No | 2026-03-11 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 1992-08-19 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2011-09-01 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2020-10-07 |
| Pap Smear Kit | OHL | Class 2 | Obstetrics/Gynecology | No | 2011-11-14 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2016-09-13 |
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)