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PT Vicinity IT Workstation
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MS17277Model 053682
Identity
- Trade Name
- PT Vicinity IT Workstation EUDAMEDFDA UDI
- Generic Name
- Desktop computer FDA UDI
- Model / Reference
- MS17277 EUDAMEDFDA UDI053682 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675053682 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04048675053682 EUDAMED
- 510(k) Number
- K060254 FDA UDI
- FDA Product Code
- MSX FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Desktop computer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Commercial Distribution
- Not 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Unsafe FDA UDI
PT Vicinity IT Workstation by Drägerwerk AG & Co. KGaA — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI af8f7a05-5b8d-4d24-a9c9-0e791ae9c182 35 fields · synced Jul 12, 2026
- EUDAMED 8be8c627-6dd5-40e8-8e59-2186347a880d 61 fields · synced Jul 12, 2026