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 RWC + miniCap FDA UDI
- Description
- Wireless Patient Monitor FDA UDI
Identifiers
- Catalog Number
- 500-0034-01 FDA UDI
- Primary DI / UDI-DI
- B3945000034010 FDA UDI
- 510(k) Number
- K191989 FDA UDI
- FDA Product Code
- MWI FDA UDIDXN FDA UDIDQA FDA UDIDRG FDA UDICCK 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 UDI870.1130 FDA UDI870.2700 FDA UDI870.2910 FDA UDI868.1400 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, clinical
WVSM Wireless Vital Signs Monitor by Athena Gtx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191989 also covers:
- WVSM Wireless Vital Signs Monitor — Athena Gtx
- WVSM Wireless Vital Signs Monitor — Athena Gtx
- WVSM Wireless Vital Signs Monitor — Athena Gtx
- WVSM Wireless Vital Signs Monitor — Athena Gtx
- WVSM Wireless Vital Signs Monitor — Athena Gtx
- WVSM Wireless Vital Signs Monitor — Athena Gtx
- WVSM Wireless Vital Signs Monitor — Athena Gtx
- WVSM Wireless Vital Signs Monitor — Athena Gtx
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 f6239bf6-e7b6-40aa-8496-10e5ba287c0c 36 fields · synced Jun 8, 2026