Home › Ambu A/S › SleepmateRIPmate Kit with Disposable Bands - STD

SleepmateRIPmate Kit with Disposable Bands - STD

Ambu A/S · Model 819200-100 · UDI-DI 05707480107186

BZQ Prescription

510(k) clearances

127

Adverse events (11 deaths)

Recalls

110

Facilities

Description

RIPmate Kit with Disposable Bands - STD

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.