FDA Registration
Active
🇺🇸 United States
ATLAS MEDICAL PRODUCTS LLC
Reg #: 3010621964
·
FEI: 3010621964
·
Expires 2026
Products
58
Proprietary Names
23
Establishment Types
1
Classifications
58
Registration Details
- Registration Name
- ATLAS MEDICAL PRODUCTS LLC
- Registration Number
- 3010621964
- FEI Number
- 3010621964
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4401 E 10th Ave
- City
- Hialeah
- State
- FL
- ZIP
- 33013
- Country
- US
Regulatory Submissions
- 510(k) Number
- K214075
Owner / Operator
- Firm Name
- Atlas Medical Products LLC
- Operator Number
- 10045445
- Address
- 4401 East 10th Avenue
- City
- Hialeah
- State
- FL
- Postal Code
- 33013
- Country
- US
- Correspondent
- Otto Morelli
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2023-08-07 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2023-08-07 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2022-09-21 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2021-03-09 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-03-09 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2023-08-07 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2022-09-21 |
| Tape, Camera, Surgical | FXN | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2022-09-21 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2022-09-21 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2023-08-03 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2022-09-21 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Speculum, Non-Illuminated | FXE | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2022-09-21 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-11-29 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2021-03-22 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2023-08-07 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2022-09-21 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2022-09-21 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2022-09-21 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2022-09-21 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2022-09-21 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2023-08-02 |
| Container, Sharps | MMK | Class 2 | General Hospital | No | 2023-08-03 |
| Shoe And Shoe Cover, Conductive | BWP | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Catheter, Nasal, Oxygen | BZB | Class 1 | Anesthesiology | No | 2022-09-21 |
| Appliance, Colostomy, Disposable | EZS | Class 1 | Gastroenterology, Urology | No | 2022-09-21 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2021-03-15 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2022-09-21 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2021-03-09 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2023-08-08 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2022-09-21 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2022-09-21 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2022-05-18 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2022-09-21 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2022-09-21 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2023-08-02 |
| Pouch, Colostomy | EZQ | Class 1 | Gastroenterology, Urology | No | 2022-09-21 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2022-09-21 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2021-03-09 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2021-03-09 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2023-08-07 |
| Catheter, Balloon Type | GBA | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 2022-09-21 |
| Catheter, Infusion | JCY | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
Proprietary Names
ROSPITAL SCAPL VEIN SET ALL SIZES
ROSPITAL GUEDELL AIRWAY
ROSPITAL Hypodermic Needle Single use Lumen, ALL SIZES
ROSPITAL PRODUCTOS MEDICOS
ROSPITAL NON STERILE SPECIME CONTAINER
Rospital Productos Medicos
ROSPITAL
ROSPITAL SPECIMEN CONTAINER, STERILE AND NONSTERILE 4OZ
ROSPITAL ESU PENCIL
ROSPITAL BLOOD COLLECTION NEEDLER HOLDER
ROSPITAL Hypodermic Safety Needle; Hypodermic Safety Needle , with Syringe, Syringes. all sixes
ROSPITAL ZINC OXIDE PLASTER WHITE 1"X10 YDS. AND 2"X0 YDS
ROSPITAL IV CATHETER PEN STYLE, NLINE, WITH WINGS AND WINGS/PORT
ROSPITAL ESU PLATE
ROSPITAL ENDOTRACHEAL TUBE
ROSPITAL SHARP CONTAINER, RED PLASTIC, 2L. AND 6L EA.
ROSPITAL SAFETY BLOOD COLLECTION SETS, BLISTER PACK 23G X 3/4" AND 25GX 3/4"
ROSPITAL SURGICAL GOWNS ALL SIZES
ROSPITAL ISOLATION GOWN
ROSPITAL FOLEY CATHETER
ROSPITAL Nitrile Blue Powder Free Examination Gloves ALL SIZES
ROSPITAL CLOSED WOUND DRAINAGE SYSTEM 10 FR AND 19 FR
ROSPITAL BLOOD COLLECTION SETS, ALL SIZES AND BLOOD COLLECTION SET ALL SIZES WITH HOLDER
Establishment Types
Repack or Relabel Medical Device