Identity
- Trade Name
- Scio Four, Oxi FDA UDI
- Generic Name
- Anaesthetic agent gas monitor, multiple FDA UDI
- Model / Reference
- 6871803 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675429326 FDA UDI
- 510(k) Number
- K051628 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Anaesthetic agent gas monitor, multiple FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Anaesthetic agent gas monitor, multiple
Scio Four, Oxi 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 plus — 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
European Union Unknown
MDR
United States Pending data
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 9a3764aa-92c0-48ea-a7a3-9af111312eaa 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026