Identity
- Trade Name
- ADVANCED VITAL SIGNS MONITOR FDA UDI
- Generic Name
- Multiple-patient intensive/general healthcare physiologic monitoring system FDA UDI
- Model / Reference
- VSM-300A FDA UDI
Identifiers
- Primary DI / UDI-DI
- B510VSM300A1 FDA UDI
- 510(k) Number
- K112465 FDA UDI
- FDA Product Code
- DQA FDA UDIDXN FDA UDIFLL FDA UDI
- GMDN Term
- Multiple-patient intensive/general healthcare physiologic monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI870.1130 FDA UDI880.2910 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
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-patient intensive/general healthcare physiologic monitoring system
Advanced Vital Signs Monitor by Advanced Instrumentations, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple-patient intensive/general healthcare physiologic monitoring system.
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Cleared under the same submission
K112465 also covers:
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
- Advanced Instrumentations, Inc.
Sources (1)
- FDA UDI 912b1e6e-2308-4f98-ac92-14bb763da10b 34 fields · synced May 30, 2026