Cincinnati Sub-Zero Products, Inc.
Cincinnati Sub-Zero Products, Inc. holds FDA 510(k) medical device clearances, first cleared 1991, most recent 2013, with 6 FDA device recalls on record.
Top product codes for Cincinnati Sub-Zero Products, Inc.
FDA recalls by Cincinnati Sub-Zero Products, Inc.
- Z-1825-2017 — Hemotherm CE, model 400CE, Heater-Cooling Device
- Z-0654-2017 — The Hemotherm 400CE 115v, containing power board p/n 39945
- Z-1129-2015 — Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.
- Z-1679-2014 — 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
- Z-2209-2013 — Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
- Z-0443-2014 — Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Cincinnati Sub-Zero Products, Inc.
- K123946 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
- K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
- K121669 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
- K120081 — NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
- K110104 — BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
- K101148 — WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS
- K101589 — BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
- K072621 — ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
- K070339 — DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES
- K942599 — WARM AIR WARMING UNIT
- K942790 — WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133)
- K910327 — WARMAIR SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.