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ThermiSense

SALTER LABS · Model 5700PS20-0 · UDI-DI 00607411099540

BZQ Prescription

510(k) clearances

127

Adverse events (11 deaths)

Recalls

111

Facilities

Description

ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6' long Malleable plastic coated "T" shaped with 2 nasal and 1 oral elements for thermal airflow. Three pin keyhole for connection to the Sandman® SD20 headbox.

Recalls

Date	Firm	Reason
2010-12-21	Salter Laboratories, Division of Regulatory Affairs	The incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment.
2004-06-04	Respironics, Inc.	Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected.
2004-05-24	CAS Medical Systems, Inc.	Device may not alarm for %SpO2 value limit violations if a specific feature is enabled

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.