Identity
- Trade Name
- ATMOS FDA UDI
- Generic Name
- Thoracic suction pump FDA UDI
- Device Name
- The ATMOS S 201 Thorax drainage system is a device for mobile, digital thoracic drainage. The device is meant for the short-term (< 30 days) application on humans. It is portable, mains independent and has an electronic monitoring system with optical and acoustic status display. FDA UDI
- Model / Reference
- S 201 Thorax FDA UDI
- Description
- The ATMOS S 201 Thorax drainage system is a device for mobile, digital thoracic drainage. The device is meant for the short-term (< 30 days) application on humans. It is portable, mains independent and has an electronic monitoring system with optical and acoustic status display. FDA UDI
Identifiers
- Catalog Number
- 312.1000.0 FDA UDI
- Primary DI / UDI-DI
- 04250365132304 FDA UDI
- 510(k) Number
- K103042 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Thoracic suction pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
Yes
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
Category: Thoracic suction pump
Atmos by ATMOS MedizinTechnik GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thoracic suction pump.
- Thoraguard — Centese, Inc. · Class II
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- Thopaz+ — Medela LLC · Class II
- Thopaz+ — Medela LLC · Class II
- Thopaz+ — Medela LLC · Class II
- Passio Pump Drainage System — BEARPAC MEDICAL, LLC · Class II
- ATMOS — ATMOS MedizinTechnik GmbH & Co. KG · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ATMOS MedizinTechnik GmbH & Co. KG
Sources (1)
- FDA UDI 4526c137-8ae9-4812-afe7-497b15fda013 35 fields · synced Jun 8, 2026