Scio Four, Oxi plus
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Scio Four, Oxi plus EUDAMEDFDA UDI
- Generic Name
- Anaesthetic agent gas monitor, multiple FDA UDI
- Model / Reference
- 6871801 EUDAMEDFDA UDI301007VK19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675429302 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751301007VK19Z0006K EUDAMED
- Direct Marketing DI
- 04048675429302 EUDAMED
- 510(k) Number
- K051628 FDA UDI
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z1203010199 ANAESTHESIA SYSTEMS - OTHER EUDAMED
- GMDN Term
- Anaesthetic agent gas monitor, multiple FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Anaesthetic agent gas monitor, multiple
Scio Four, Oxi plus by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthetic agent gas monitor, multiple.
- Gas Sample Line Set — MIPM Mammendorfer Institut für Physik und Medizin GmbH · Class II
- Iradimed — Iradimed Corporation · Class II
- MEDRAD® Veris™ 8600 Vital Signs Monitor — Bayer Medical Care Inc. · Class II
- MEDRAD® Veris™ 8600 Vital Signs Monitor — Bayer Medical Care Inc. · Class II
- Scio Four, Oxi — Drägerwerk AG & Co. KGaA · Class II
- Vamos 2 — Drägerwerk AG & Co. KGaA · Class II
- Scio Four, plus — Drägerwerk AG & Co. KGaA · Class II
Cleared under the same submission
K051628 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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 9b549535-eed0-4b11-8cab-28ccfcdf2df2 34 fields · synced Jul 25, 2026
- EUDAMED d0164ad4-fec6-4a28-9b36-4f3a0ac3c0eb 61 fields · synced Jul 25, 2026