Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005382983

FEI Number

3005382983

Entity Name

COMMAND MEDICAL NICARAGUA SA

City/State/Country

Managua, NI

Establishment Address

Km 12.5 Carretera Norte, Parque Industrial Las Mercedes, Edificio 16, Managua --, NI

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

COMMAND MEDICAL PRODUCTS, LLC (Owner Number: 1526611)

Owner / Operator Contact Address

15 Signal Avenue, Ormond Beach, FL 32174, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IPC Visao Cooling Set (66320555E / M029211C001) OB IPC/XPS Suction Irrigation Tubing Set (66320510E / M029210C001) Indigo Tubing (M029215C001) OB CV000002714 CV000002714N PureView Active Laparoscopic Plume Filtration Device (MDL 904235 and MDL 904145) PlumePort ActiV Surgical Smoke Plume Evactuation Tubing (MDL 300338 and 300340) PlumePort ActiV Surgical Smoke Plume Evacuation Tubing (MDL PP001CS and PP010CS) LigaSure Maryland Jaw Sealer/Divider One-step Sealing Nano-Coated Bag Blank Tubing Set, Clearview MR8 (M031345C001) Tubing Set, Clearview MR8 (M031346C001) M726750C030/ M029216C001 NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) Irrigation Tubing (M030560C001) LigaSure Maryland Jaw Sealer/Divider One-step Sealing Nano-Coated FluidSmart

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2013-03-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-04-05
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-03-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-08-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-08-15
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2020-08-26
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2014-02-21
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2014-02-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-01-29
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2022-06-15
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2014-02-21
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-02-21
FFS	Image, Illumination, Fiberoptic, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2014-02-21
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2016-11-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-08-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-08-15
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2025-03-24
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2025-03-24
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2025-03-24
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2025-03-24
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2025-03-24
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2013-03-13
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2016-11-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-01-13
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-03-13
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-03-13
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-03-13
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2013-03-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-03-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-06-04
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2015-10-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-01-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-02-06
QAI	Powered Microneedle Device	General, Plastic Surgery	Class 2	878.4430	2018-11-02
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2018-01-08
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2018-01-08
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2018-01-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-08-15
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2013-08-15

Official Correspondent

No official correspondent registered.

US Agent Details

Michael Letterman Business: Command Medical Products Inc. Email: mletterman@commandmedical.com Phone: (386) 6728116

Related Public Records

Same Entity

COMMAND MEDICAL PRODUCTS, 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
1526611	Command Medical Products, LLC.	ORMOND BEACH, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
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.

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3003120897	MEDTRONIC SOFAMOR DANEK USA, INC.	Memphis, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005382983. Last updated year: 2026. Please use registration number 3005382983 when referencing this establishment in official correspondence.