Identity
- Trade Name
- MedSource Kit 3, Orange (System 3 Kit, w/inf cuff) FDA UDI
- Generic Name
- Patient monitoring system module, blood pressure, noninvasive FDA UDI
- Device Name
- Kit 3, Orange (System 3 Kit, w/inf cuff) FDA UDI
- Model / Reference
- MS-MED3O_USA FDA UDI
- Description
- Kit 3, Orange (System 3 Kit, w/inf cuff) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816703021224 FDA UDI
- FDA Product Code
- LHI FDA UDI
- GMDN Term
- Patient monitoring system module, blood pressure, noninvasive FDA UDI
- Models / Variants
- System 3 Kit FDA UDIw FDA UDIinf cuff FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Patient monitoring system module, blood pressure, noninvasive
MedSource Kit 3, Orange (System 3 Kit +2 more) by Medsource International Llc — Class II — FDA UDI — listed in FDA GUDID — 3 models
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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
- Medsource International Llc
Sources (1)
- FDA UDI f31343fd-933a-4a50-8228-a0c8c122825e 33 fields · synced May 31, 2026