Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000122786

FEI Number

1000122786

Entity Name

DRE Med

City/State/Country

Louisville, KY, US

Establishment Address

2601 Stanley Gault PKWY, Louisville, KY 40223, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DRE Resume LLC (Owner Number: 10092249)

Owner / Operator Contact Address

2601 Stanley Gault Pkwy, STE 101, Louisville, KY 40223, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131818

PMA Number

N/A

All Registered Proprietary Names

DRE True 12T Electrocardiograph DRE Waveline Nano B2 Pulse Oximeter AV-S Anesthesia Ventilator DRE Waveline EZ Monitor DRE Compact FM Fetal Monitor DRE Compact II Fetal Monitor DRE Citadel 200 Electrosurgical Unit DRE Citadel Trio Electrosurgical Unit DRE Citadel EZ Electrosurgical Unit DRE True Advance Electrocardiograph DRE Wildcat 750 Patient Warmer DRE Vision EX5 Minor Procedure Light DRE Vista LED Procedure Light DRE Avela Procedure Chair DRE Milano Series Chairs DRE Integra VS02 Anesthesia Machine DRE Premio E250 Hospital Bed DRE Marseille MMT DRE Milano Series Chairs DRE Orthopedic Extension DRE DM-660 Suction Pump DRE Waveline EZ-Max V2 Monitor DRE Infantia NB 500 Incubator DRE Vision LED Surgical Light DRE Maxx Luxx LED Surgical Light DRE Comfort Series Warmer DRE Waveline Pro Monitor DRE VLM Laryngoscope DRE InView Laryngoscope DRE Millennium 5 Stretcher DRE Millennium G700 Stretcher DRE Trax Monitor DRE LA-540 Aspirator DRE One Room Package DRE Velocity PC-Based Electrocardiograph DRE Envoy FM Central Monitoring System DRE Waveline Touch Monitor DRE Echo Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2024-12-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-12-18
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-12-17
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-12-17
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2024-12-18
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2024-12-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-12-18
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2024-12-18
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2024-12-17
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2024-12-18
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	Class 1	878.4960	2024-12-17
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2024-12-17
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2024-12-17
FSE	Table, Operating-Room, Manual	General, Plastic Surgery	Class 1	878.4950	2024-12-17
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2024-12-18
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2024-12-18
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2024-12-18
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2024-12-18
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2024-12-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-12-18
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2024-12-18
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2024-12-18
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2024-12-18
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2024-12-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-12-18
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2024-12-18
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2024-12-18
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2024-12-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-12-18
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2024-12-17
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2024-12-18
LHC	Warmer, Irrigation Solution	Physical Medicine	Class 1	890.5950	2024-12-18
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-12-18
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2024-12-18
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2024-12-18
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-12-17
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2024-12-18
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2024-12-18
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2024-12-18
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2024-12-17
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-12-17
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-12-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-12-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-12-18

Official Correspondent

Carlos Borges

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DRE Resume 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
K862544	Suzuken Co., Ltd.	KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH	1986-08-06
K802368	Marquette Electronics, Inc.	OPTION 301 PACEMAKER EVAL. MODULE MAC-1	1981-03-04
K131503	Edan Instruments, Inc.	SE-601 SERIES ELECTROCARDIOGRAPH	2014-02-25
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2022	Welch Allyn Inc Mortara	2	ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D
Z-0041-2012	Edan Instruments, Inc. 7/F, Yuehai Office Bldg. 1128 Nanyou Road Nanshan, Shenzhen Guangdong China	2	ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000122786. Last updated year: 2026. Please use registration number 1000122786 when referencing this establishment in official correspondence.