Identity
- Trade Name
- Thermal Printer Kit, USB EUDAMEDFDA UDI
- Generic Name
- Paper chart recorder FDA UDI
- Device Name
- Printer and Paper Chart Recorder EUDAMEDNon-MRI, Thermal Printer Kit, USB for MR Patient Care Portal 5000. Includes printer with USB cable and Power cable FDA UDI
- Model / Reference
- 989803205011 EUDAMEDThermal Printer Kit, USB FDA UDI
- Description
- Non-MRI, Thermal Printer Kit, USB for MR Patient Care Portal 5000. Includes printer with USB cable and Power cable FDA UDI
Identifiers
- Catalog Number
- 989803205011 FDA UDI
- Primary DI / UDI-DI
- 00884838093928 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM461T2 EUDAMED
- FDA Product Code
- DSF FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Paper chart recorder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 870.2810 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Thermal Printer Kit, USB by Invivo, a division of Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM461T2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Invivo, a division of Philips Medical Systems
- EUDAMED SRN
- US-MF-000002177
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (3)
- EUDAMED b9d285ca-a86a-4809-b42f-50a1d620b7d7 61 fields · synced Jun 17, 2026
- FDA UDI 40613902-23fd-43af-97f4-0c91069a2399 35 fields · synced May 30, 2026
- EUDAMED 7327513a-76c2-4f1b-84cd-0db6cd8f5360 61 fields · synced Jun 11, 2026