Identity
- Trade Name
- WVSM Wireless Vital Signs Monitor FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- Wireless Patient Monitor FDA UDI
- Model / Reference
- WVSM 5.0 FDA UDI
- Description
- Wireless Patient Monitor FDA UDI
Identifiers
- Catalog Number
- 500-0001-12 FDA UDI
- Primary DI / UDI-DI
- B3945000001120 FDA UDI
- FDA Product Code
- MWI FDA UDIDQA FDA UDIDRG FDA UDIDXN FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 FDA UDI870.2700 FDA UDI870.2910 FDA UDI870.1130 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: Multiple vital physiological parameter monitoring system, clinicalMultiple-patient intensive/general healthcare physiologic monitoring system
WVSM Wireless Vital Signs Monitor by Athena Gtx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Athena Gtx
Sources (1)
- FDA UDI d0af3a77-3440-4ba2-938e-3ddd419db872 36 fields · synced Jun 7, 2026