Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010317211

FEI Number

3010317211

Entity Name

TRIBALCO

City/State/Country

Tampa, FL, US

Establishment Address

1802 Grant St Ste 300, Tampa, FL 33605, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Tribalco (Owner Number: 10044850)

Owner / Operator Contact Address

1802 Grant St, Suite 300, Tampa, FL 33605, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090508

PMA Number

N/A

All Registered Proprietary Names

MEQU Warmer System Ventway Sparrow Zoll Propaq MD C MAC 8403 Video Laryngoscope RAD 57 Thermometer Model 9550, Onyx II; Model 9570; Model 9571; Model 9590; Onyx Vantage Monitor TEMPUS PRO PATIENT MONITOR Geratherm Mini Rescue II R130 Generator SAROS Oxygen System Model 3000 The Belmont buddy lite Blood/Fluid Warmer; The Belmont buddy lite Fluid Warmer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2026-02-20
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2026-02-20
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2023-12-14
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-12-23
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-12-23
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-12-23
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2022-12-23
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2022-12-23
LIX	Aid, Cardiopulmonary Resuscitation	Cardiovascular	Class 2	870.5210	2022-12-23
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-12-23
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-12-23
DRO	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	Cardiovascular	Class 2	870.5550	2022-12-23
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2021-12-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-12-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-08-08
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-01-13
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2013-08-08
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2021-12-15
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2013-08-08
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2020-01-13

Official Correspondent

Patricia Becker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tribalco

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
K090508	Belmont Instrument Corp.	THE BELMONT BUDDY LITE FLUID WARMER	2009-03-26
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31
K832250	Litton Medical Electronics	SERVOMED BASIC BEDSIDE UNIT SMA 102-	1984-06-01
K801515	Abbott Medical Electronics Co.	ABBY II PATIENT MONITOR OR VITAL SIGNS M	1980-07-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010317211. Last updated year: 2026. Please use registration number 3010317211 when referencing this establishment in official correspondence.