Identity
- Trade Name
- MiniBox FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- The MiniBox is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes ). The MiniBox is to be used by either a physician, respiratory therapist, or technician. A cleared single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.The MiniBox measures all common spirometric measurements as well as relative and absolute lung volumes. FDA UDI
- Model / Reference
- MiniBox FDA UDI
- Description
- The MiniBox is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes ). The MiniBox is to be used by either a physician, respiratory therapist, or technician. A cleared single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.The MiniBox measures all common spirometric measurements as well as relative and absolute lung volumes. FDA UDI
Identifiers
- Catalog Number
- PUO-MiniBox FDA UDI
- Primary DI / UDI-DI
- 07290016675009 FDA UDI
- 510(k) Number
- K141793 FDA UDI
- FDA Product Code
- BZC FDA UDIBZG FDA UDI
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1880 FDA UDI868.1840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary function analysis system, adultDiagnostic spirometer, professional
MiniBox by Pulmone Advanced Medical Devices, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Diagnostic spirometer, professional.
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- Alpha — Vitalograph Ireland, Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pulmone Advanced Medical Devices, Ltd.
Sources (1)
- FDA UDI d8139997-5385-43f0-8345-e501b13de4fd 35 fields · synced May 30, 2026