FDA Registration
Active
🇺🇸 United States
GlobalMed Holdings, LLC
Reg #: 3004009431
·
FEI: 3004009431
·
Expires 2026
Products
17
Proprietary Names
20
Establishment Types
3
Classifications
17
Registration Details
- Registration Name
- GlobalMed Holdings, LLC
- Registration Number
- 3004009431
- FEI Number
- 3004009431
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 15020 North 74th Street
- City
- Scottsdale
- State
- AZ
- ZIP
- 85260
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130624
Owner / Operator
- Firm Name
- GlobalMed Holdings, LLC
- Operator Number
- 10033888
- Address
- 15023 N 73rd Street
- City
- Scottsdale
- State
- AZ
- Postal Code
- 85260
- Country
- US
- Correspondent
- Michael Johnson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2013-05-10 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-11-21 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-11-21 |
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2024-11-21 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2024-11-21 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2024-11-21 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-11-21 |
| Accessories To Examination Light | PEQ | Class 1 | General Hospital | No | 2013-07-15 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2024-11-23 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2024-11-23 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2020-08-10 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2020-08-10 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2010-10-14 |
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2020-08-10 |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2020-08-10 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2020-08-10 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2011-05-13 |
Proprietary Names
eNcounter Cloud
TotalVitals
Variable Polarizing Hood
ClearProbe; Interson Seemore Ultasound Probe
ClearProbe, Interson Simpli Series Ultrasound Probe
TotalExam 3
TotalExam 2
Total Exam Oto
Total Exam Lite
Clear Steth
Total ECG
Clinical Access Station (CAS)
CAS Lite
WallDoc
Transportable Exam Station (TES)
Lite Exam Station
Next Exam Station
First Exam Station
eNcounter®
ClinicalAccess Pro Connect
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device