FDA Registration
Active
🇺🇸 United States
Mazza Healthcare LLC
Reg #: 3007407626
·
FEI: 3007407626
·
Expires 2026
Products
38
Proprietary Names
5
Establishment Types
1
Classifications
38
Registration Details
- Registration Name
- Mazza Healthcare LLC
- Registration Number
- 3007407626
- FEI Number
- 3007407626
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 100 Tri State Intl Ste 125
- City
- Lincolnshire
- State
- IL
- ZIP
- 60069
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171131
Owner / Operator
- Firm Name
- Mazza Healthcare, LLC
- Operator Number
- 10028309
- Address
- 100 Tri-State International, Suite 125
- City
- Lincolnshire
- State
- IL
- Postal Code
- 60069
- Country
- US
- Correspondent
- Michael A Mazza
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2023-03-13 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2021-08-25 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2023-03-13 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2023-03-13 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2022-05-04 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2021-08-25 |
| Pill Crusher/Cutter | OHY | Class 1 | General Hospital | No | 2023-03-13 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2019-05-29 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2024-02-27 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2021-08-25 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2023-11-27 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-12-09 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-08-25 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2023-03-13 |
| Scale, Stand-On, Patient | FRI | Class 1 | General Hospital | No | 2023-01-26 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2021-08-25 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2021-08-25 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2021-08-25 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-11-27 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-11-27 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2022-12-09 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2025-12-10 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2025-12-10 |
| Scale, Patient | FRW | Class 1 | General Hospital | No | 2023-01-26 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-12-09 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2025-12-10 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2021-08-25 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2021-08-25 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2023-05-10 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2024-09-25 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2023-03-13 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2021-08-25 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2023-03-13 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2023-03-13 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2021-08-25 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2021-08-25 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2023-03-13 |
| Counter, Sponge, Surgical | LWH | Class 1 | General Hospital | No | 2023-05-10 |
Proprietary Names
HCS
Aesculap
Mazza
Mazza Healthcare
MH
Establishment Types
Complaint File Establishment per 21 CFR 820.198