Identity
- Trade Name
- LSU w/Reusable Canister, Canadian French FDA UDI
- Generic Name
- Emergency airway clearance suction system, electric FDA UDI
- Device Name
- The LSU is a portable, electrically powered, medical suction equipment 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. Hight vacuum levels are generally selected for oropharyngeal suctioning, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants. FDA UDI
- Model / Reference
- 78000016 FDA UDI
- Description
- The LSU is a portable, electrically powered, medical suction equipment 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. Hight vacuum levels are generally selected for oropharyngeal suctioning, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants. FDA UDI
Identifiers
- Catalog Number
- 78000016 FDA UDI
- Primary DI / UDI-DI
- 07045430042087 FDA UDI
- 510(k) Number
- K993668 FDA UDI
- FDA Product Code
- BTA 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
No
FDA UDI
LSU w/Reusable Canister, Canadian French by Laerdal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Laerdal Medical Corp.
Sources (1)
- FDA UDI 456a010f-7d08-4521-abdb-a7cbf00e6a02 38 fields · synced May 30, 2026