FDA UDI
In Commercial Distribution
🇺🇸 United States
MESI mTABLET SPIRO
DI: 03830059852216
·
Model: MTABSYSSPIRO
·
MESI d.o.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MESI mTABLET SPIRO
- Primary DI
- 03830059852216
- Version / Model
- MTABSYSSPIRO
- Company Name
- MESI d.o.o.
- Labeler DUNS
- 500719478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-24
- Public Version
- 1
- Public Version Date
- 2026-04-01
- Public Version Status
- New
- Public Device Record Key
- 1b6fd806-59ba-4699-aa78-2c6000add35e
Device Description
The MESI mTABLET SPIRO is an automated wireless spirometer device for diagnosing and screening patients with respiratory diseases. The system is intended to perform, view and store spirometry measurements of adult and paediatric patients. It is a wireless system which is comprised of a wireless medical grade tablet, spirometer module, disposable mouthpieces and charging station module.
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 Unsafe
- 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
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZG | Spirometer, Diagnostic | Anesthesiology | 868.1840 | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03830059852216 | GS1 |
Customer Contacts
- Phone
- +38616203487
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251777 | 000 |