Identity
- Trade Name
- Monitor System, Patient Display FDA UDI
- Generic Name
- Breath-hold system remote display FDA UDI
- Device Name
- Interactive Breath Hold - Monitor System, Patient Display FDA UDI
- Model / Reference
- 43T2564 FDA UDI
- Description
- Interactive Breath Hold - Monitor System, Patient Display FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851607003129 FDA UDI
- FDA Product Code
- HCC FDA UDI
- GMDN Term
- Breath-hold system remote display FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breath-hold system remote display
Monitor System, Patient Display by Medspira Llc — 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
- Medspira Llc
Sources (1)
- FDA UDI a4d3d3b2-e88e-494d-9f3f-1765010e62f8 34 fields · synced Jun 8, 2026