Identity
- Trade Name
- ATMOS C 451 EUDAMEDATMOS FDA UDI
- Generic Name
- General-purpose suction system, line-powered FDA UDI
- Device Name
- Suction unit, surgical EUDAMEDMedical suction unit for suction of secretions, blood, serous fluids, rinsing fluids and temporarily collection of this fluids FDA UDI
- Model / Reference
- 340.0300.0 EUDAMEDC 451 FDA UDI
- Description
- Medical suction unit for suction of secretions, blood, serous fluids, rinsing fluids and temporarily collection of this fluids FDA UDI
Identifiers
- Catalog Number
- 340.0300.2 FDA UDI
- Primary DI / UDI-DI
- 04250365135992 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250365135992 EUDAMED
- 510(k) Number
- K090445 FDA UDI
- FDA Product Code
- BTA FDA UDI
- EMDN Code
- Z120105 SURGICAL MEDICAL ASPIRATORS EUDAMED
- GMDN Term
- General-purpose suction system, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Atmos C 451 by ATMOS MedizinTechnik GmbH & Co. KG — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250365135992 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ATMOS MedizinTechnik GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005570
Sources (2)
- EUDAMED eabeb795-ec08-428c-8ffb-08fca9a34601 61 fields · synced Jun 18, 2026
- FDA UDI 45996217-82e8-49f9-90ca-0f11080fea1b 35 fields · synced May 29, 2026