FDA UDI
In Commercial Distribution
🇺🇸 United States
MIR
DI: 08052990320868
·
Model: MIR Spirobank II New spirometer and oximeter
·
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MIR
- Primary DI
- 08052990320868
- Version / Model
- MIR Spirobank II New spirometer and oximeter
- Company Name
- MIR MEDICAL INTERNATIONAL RESEARCH SPA
- Labeler DUNS
- 630129930
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-27
- Public Version
- 5
- Public Version Date
- 2024-01-12
- Public Version Status
- Update
- Public Device Record Key
- f463149d-915c-4ad2-a62c-c77490290481
Device Description
Portable spirometer for lung function testing with oximetry function with reusable turbine
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| BZG | Spirometer, Diagnostic | Anesthesiology | 868.1840 | 2 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46906 | Expiratory peak flow meter, digital | A battery-powered, hand-held, electronic instrument designed to measure the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] and forced expiratory volume (FEV) from the lungs. It typically includes a mouthpiece for patient exhalation and a digital display [e.g., liquid-crystal display (LCD)]; it may include a port for communicating with a computer/tablet. The device is typically intended to monitor the respiratory status of a patient affected by chronic respiratory disorders (e.g., asthma, emphysema) in a clinical setting or the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08052990320868 | GS1 |
Customer Contacts
- Phone
- +390622754777
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061712 | 000 |