FDA UDI
In Commercial Distribution
🇺🇸 United States
MasterScope
DI: 04057155000641
·
Model: MasterScope WSSU with ECG
·
eResearchTechnology GmbH
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- MasterScope
- Primary DI
- 04057155000641
- Version / Model
- MasterScope WSSU with ECG
- Company Name
- eResearchTechnology GmbH
- Labeler DUNS
- 341625331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-14
- Public Version
- 4
- Public Version Date
- 2024-03-19
- Public Version Status
- Update
- Public Device Record Key
- 7541edbd-213b-4b19-8571-91acb9d30fdc
Device Description
diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | Anesthesiology | 868.1890 | 2 |
| DPS | Electrocardiograph | Cardiovascular | 870.2340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13680 | Diagnostic spirometer, professional | An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders. | No | Active |
| 16231 | Electrocardiograph, professional, multichannel | A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04057155000641 | GS1 |
Customer Contacts
- Phone
- +4993057209891
- [email protected]
- Phone
- +1 908 5952020
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202754 | 000 |