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Lcsu 4
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 880061Model LCSU 4, 300 ml, Complete unit
Identity
- Trade Name
- LCSU 4 EUDAMEDLCSU 4, 300 ml, Complete Unit FDA UDI
- Generic Name
- Emergency airway clearance suction system, electric FDA UDI
- Device Name
- Laerdal Compact Suction Unit (LCSU) 4 EUDAMEDThe LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient’s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants. FDA UDI
- Model / Reference
- LCSU 4, 300 ml, Complete unit EUDAMED880061 EUDAMEDFDA UDI
- Description
- The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient’s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants. FDA UDI
Identifiers
- Catalog Number
- 880061 FDA UDI
- Primary DI / UDI-DI
- 07045432088526 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07045432088526 EUDAMED
- 510(k) Number
- K120065 FDA UDI
- FDA Product Code
- JCX FDA UDI
- EMDN Code
- R0599 RESPIRATORY DEVICES, SUCTION AND DILATION SYSTEMS - OTHER EUDAMED
- GMDN Term
- Emergency airway clearance suction system, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Norway 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Lcsu 4 by Laerdal Medical AS — 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-07045432088526 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-MF-000000012
Sources (2)
- EUDAMED b7e88381-599e-470a-a97e-f7a4b46b5d37 61 fields · synced Jul 10, 2026
- FDA UDI d26e2b2c-67c6-4b61-9093-8bf461a96bdc 37 fields · synced May 29, 2026