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Atrium Express Mini 500 Dry Seal Chest Drainl, Infant/ Pediatric Chest Drains
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 16400
Identity
- Trade Name
- Atrium Express Mini 500 Dry Seal Chest Drainl, Infant/ Pediatric Chest Drains EUDAMEDEXPRESS FDA UDI
- Generic Name
- Thoracic suction collection container FDA UDI
- Device Name
- Atrium Express Mini 500 Chest Drain EUDAMEDEXPRESS MINI 500 DRAIN FDA UDI
- Model / Reference
- 16400 EUDAMEDFDA UDI
- Description
- EXPRESS MINI 500 DRAIN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00650862164008 EUDAMEDFDA UDI
- Basic UDI-DI
- 0650862RA000120ZA EUDAMED
- 510(k) Number
- K984496 FDA UDI
- FDA Product Code
- KDQ FDA UDI
- EMDN Code
- A0699 DRAINAGE AND FLUID COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Thoracic suction collection container FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Atrium Express Mini 500 Dry Seal Chest Drainl, Infant/ Pediatric Chest Drains by Atrium Medical Corporation — Class I — FDA_510K, MDR — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K984496 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0650862RA000120ZA | Class I | Active |
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Manufacturer
- Manufacturer
- Atrium Medical Corporation
- EUDAMED SRN
- US-MF-000003282
- Authorised Representative
- MAQUET Critical Care AB SE-AR-000001442
Sources (3)
- EUDAMED dfbd7587-4de6-4be4-8e72-068661f82856 61 fields · synced Jul 11, 2026
- FDA UDI 00739cb5-22b0-4917-b6ad-87e063d49a30 35 fields · synced May 30, 2026
- FDA 510(k) K984496 1 fields · synced May 18, 2026