Identity
- Trade Name
- PHILIPS IntelliVue Spirometry Module FDA UDI
- Generic Name
- Monitoring spirometer, electrical FDA UDI
- Device Name
- IntelliVue Spirometry Module for use with IntelliVue Patient Monitors. The Module allows real-time monitoring of airway flow, airway volume and airway pressure FDA UDI
- Model / Reference
- IntelliVue Spirometry Module FDA UDI
- Description
- IntelliVue Spirometry Module for use with IntelliVue Patient Monitors. The Module allows real-time monitoring of airway flow, airway volume and airway pressure FDA UDI
Identifiers
- Catalog Number
- 865021 FDA UDI
- Primary DI / UDI-DI
- 00884838020979 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Monitoring spirometer, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
MR Unsafe FDA UDI
PHILIPS IntelliVue Spirometry Module by Philips Medizin Systeme Böblingen GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Philips Medizin Systeme Böblingen GmbH
Sources (1)
- FDA UDI f4b8507d-fd88-4000-a280-34677c3b8042 37 fields · synced May 30, 2026