Identity
- Trade Name
- eCareManager FDA UDI
- Generic Name
- Patient health record information system application software FDA UDI
- Device Name
- Telehealth Center Product License FDA UDI
- Model / Reference
- 4 FDA UDI
- Description
- Telehealth Center Product License FDA UDI
Identifiers
- Catalog Number
- 865325 FDA UDI
- Primary DI / UDI-DI
- 00884838126381 FDA UDI
- 510(k) Number
- K211046 FDA UDI
- FDA Product Code
- MSX FDA UDI
- GMDN Term
- Patient health record information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Patient health record information system application software
eCareManager by Philips Medical Systems Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K211046 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
- Philips Medical Systems Nederland B.V.
Sources (1)
- FDA UDI 97b09fe3-135d-4bc6-9cdc-f6d4ad3103eb 36 fields · synced Sep 18, 2026