Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010621964

FEI Number

3010621964

Entity Name

ATLAS MEDICAL PRODUCTS LLC

City/State/Country

Hialeah, FL, US

Establishment Address

4401 E 10th Ave, Hialeah, FL 33013, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Atlas Medical Products LLC (Owner Number: 10045445)

Owner / Operator Contact Address

4401 East 10th Avenue, Hialeah, FL 33013, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 PRODUCTOS MEDICOS ROSPITAL ROSPITAL PRODUCTOS MEDICOS Rospital Productos Medicos ROSPITAL SPECIMEN CONTAINER, STERILE AND NONSTERILE 4OZ ROSPITAL PRODUCTOS MEDICOS ROSPITAL PRODUCTOS MEDICOS ROSPITAL PRODUCTOS MEDICOS ROSPITAL ROSPITAL PRODUCTOS MEDICOS ROSPITAL ESU PENCIL ROSPITAL PRODUCTOS MEDICOS ROSPITAL BLOOD COLLECTION NEEDLER HOLDER ROSPITAL Hypodermic Safety Needle; Hypodermic Safety Needle , with Syringe, Syringes. all sixes ROSPITAL PRODUCTOS MEDICOS ROSPITAL PRODUCTOS MEDICOS ROSPITAL PRODUCTOS MEDICOS ROSPITAL ZINC OXIDE PLASTER WHITE 1"X10 YDS. AND 2"X0 YDS ROSPITAL PRODUCTOS MEDICOS ROSPITAL IV CATHETER PEN STYLE, NLINE, WITH WINGS AND WINGS/PORT ROSPITAL PRODUCTOS MEDICOS ROSPITAL PRODUCTOS MEDICOS ROSPITAL PRODUCTOS MEDICOS ROSPITAL PRODUCTOS MEDICOS ROSPITAL ESU PLATE ROSPITAL PRODUCTOS MEDICOS ROSPITAL PRODUCTOS MEDICOS ROSPITAL ENDOTRACHEAL TUBE ROSPITAL SHARP CONTAINER, RED PLASTIC, 2L. AND 6L EA. ROSPITAL PRODUCTOS MEDICOS ROSPITAL PRODUCTOS MEDICOS ROSPITAL PRODUCTOS MEDICOS ROSPITAL SAFETY BLOOD COLLECTION SETS, BLISTER PACK 23G X 3/4" AND 25GX 3/4" ROSPITAL PRODUCTOS MEDICOS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-08-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-08-07
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2022-09-21
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2021-03-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-03-09
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-03-09
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-09-21
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2023-08-07
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2022-09-21
FXN	Tape, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2022-09-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-08-18
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2022-09-21
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2022-09-21
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2023-08-03
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2022-09-21
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2022-09-21
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2022-09-21
FXE	Speculum, Non-Illuminated	General, Plastic Surgery	Class 1	878.1800	2022-09-21
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-09-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-29
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2022-09-21
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2021-03-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-03-14
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2022-03-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-03-14
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2022-09-21
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2022-09-21
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2022-09-21
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-09-21
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-09-21
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2023-08-07
FME	Gown, Examination	General Hospital	Class 1	880.6265	2022-09-21
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2022-09-21
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2022-09-21
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2022-09-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-29
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2022-09-21
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2022-09-21
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2023-08-02
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2023-08-03
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2022-09-21
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2022-09-21
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2022-09-21
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2021-03-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-03-15
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2022-09-21

Official Correspondent

Otto Morelli

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Atlas Medical Products LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010621964. Last updated year: 2026. Please use registration number 3010621964 when referencing this establishment in official correspondence.