Identity
- Trade Name
- M9264-PCD-200, Pressure Tube FDA UDI
- Generic Name
- Spirometry/pulmonary function pressure tube FDA UDI
- Model / Reference
- M9264-PCD-200 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06420099001124 FDA UDI
- FDA Product Code
- BYX FDA UDI
- GMDN Term
- Spirometry/pulmonary function pressure tube FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5860 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Spirometry/pulmonary function pressure tube
M9264-PCD-200, Pressure Tube by Medikro Oy — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medikro Oy
Sources (2)
- FDA UDI 27739628-6bd0-4c42-a044-6a7e079aebfb 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026