Atlan A350 XL
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Atlan A350 XL EUDAMEDFDA UDI
- Generic Name
- Anaesthesia workstation, general-purpose FDA UDI
- Device Name
- Available with either electronically or mechanically controlled gas mixer variant FDA UDI
- Model / Reference
- 8621600 EUDAMEDFDA UDI301035FK19T010 EUDAMED
- Description
- Available with either electronically or mechanically controlled gas mixer variant FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675556183 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751301035FK19T010V2 EUDAMED
- Direct Marketing DI
- 04048675556183 EUDAMED
- 510(k) Number
- K230931 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- EMDN Code
- Z1203010101 ANAESTHESIA DEVICES EUDAMED
- GMDN Term
- Anaesthesia workstation, general-purpose FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5160 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
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
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: Anaesthesia workstation, general-purpose
Atlan A350 XL by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia workstation, general-purpose.
- A9800 Anesthesia Workstation — ORICARE INC. · Class II
- A9800 Anesthesia Workstation — ORICARE INC. · Class II
- Extra Volume reflector — Maquet Critical Care AB · Class II
- Vaporizer Desflurane, Saf-Fil — Maquet Critical Care AB · Class II
- Vaporizer Sevoflurane, MAQUET filling — Maquet Critical Care AB · Class II
- A9800 Anesthesia Workstation — ORICARE INC. · Class II
- A9800 Anesthesia Workstation — ORICARE INC. · Class II
- A9800 Anesthesia Workstation — ORICARE INC. · Class II
Cleared under the same submission
K230931 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI a1348bb8-9daa-4d8d-9d41-1431c5e59820 34 fields · synced Jun 19, 2026
- EUDAMED de729673-dc1b-4f85-bc30-5692dc196734 61 fields · synced Jun 19, 2026