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510(k) Data Aggregation
K Number
K011907Device Name
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
Manufacturer
SIMS LEVEL 1, INC.
Date Cleared
2001-12-18
(183 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
SIMS LEVEL 1, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Snuggle Warm 4000 Convective Warming System is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket system to reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Device Description
The Snuggle Warm consists of a disposable single use warming blanket that is placed in contact with the patient and a warming unit with a hose end temperature control connected to the blanket. The warming unit generates warm air that is distributed throughout the warming blanket to warm the patient during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
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K Number
K001764Device Name
HOTLINE 2 FLUID WARMER
Manufacturer
SIMS LEVEL 1, INC.
Date Cleared
2000-08-09
(58 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SIMS LEVEL 1, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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