Identity
- Trade Name
- VitalScan ANS FDA UDI
- Generic Name
- Electrocardiograph, professional, single-channel FDA UDI
- Model / Reference
- HW10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08690020003017 FDA UDI
- 510(k) Number
- K191266 FDA UDI
- FDA Product Code
- DPS FDA UDIDXN FDA UDIJOM FDA UDI
- GMDN Term
- Electrocardiograph, professional, single-channel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 FDA UDI870.1130 FDA UDI870.2780 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, non-portablePulse Co-oximeter probe, reusableElectrocardiograph, professional, single-channel
VitalScan ANS by Medeia Inc — 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
- Medeia Inc
Sources (1)
- FDA UDI 067a9589-2c0b-4260-8ab7-424824581862 33 fields · synced Jun 1, 2026