Identity
- Trade Name
- PowerCube+ Series FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- The PowerCube Body+ and Diffusion+ include an extra-large body plethysmography chamber. FDA UDI
- Model / Reference
- A FDA UDI
- Description
- The PowerCube Body+ and Diffusion+ include an extra-large body plethysmography chamber. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07613365500431 FDA UDI
- FDA Product Code
- JEH FDA UDIBZG FDA UDI
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1760 FDA UDI868.1840 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
Yes
FDA UDI
PowerCube+ Series by Ganshorn Medizin Electronic 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
- Ganshorn Medizin Electronic GmbH
Sources (1)
- FDA UDI e0fa8bad-b7aa-430d-9f84-f7c5ba0e7ee6 34 fields · synced May 30, 2026