Identity
- Trade Name
- LCSU4, 800 ml Complete unit (US) FDA UDI
- Generic Name
- Emergency airway clearance suction system, electric FDA UDI
- Device Name
- 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
- Model / Reference
- 88005101 FDA 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
- 88005101 FDA UDI
- Primary DI / UDI-DI
- 07045432046595 FDA UDI
- 510(k) Number
- K120065 FDA UDI
- FDA Product Code
- JCX FDA UDI
- GMDN Term
- Emergency airway clearance suction system, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Commercial Distribution
- Not 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
LCSU4, 800 ml Complete unit (US) by Laerdal Medical Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Laerdal Medical Corp.
Sources (2)
- FDA UDI b50cdc6e-3734-45b0-bbb3-a4561a87f64e 38 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026