Braun ThermoScan 7+ Connect, IRT6575NWE

Organization name

KAZ Europe Sàrl

SRN

CH-MF-000029980

Manufacturer status

Active

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• CW018

  EUDAMED did not publish a description for this code.
• CW014

  EUDAMED did not publish a description for this code.
• CW999

  This product is not intended to diagnose any disease but is a useful screening tool for temperature. This thermometer is not intended for clinical use in a professional environment and is for home usage only. The Age Precision™ Technology feature is not intended for pre-term babies or small-for-gestational age babies. This thermometer is not intended to interpret hypothermic temperatures. Do not allow children under 12 to take their temperatures unattended. Use of the IRT6575 is not intended as a substitute for consultation with your physician
• CW999

  Please consult your physician if you see symptoms such as unexplained irritability, vomiting, diarrhea, dehydration, changes in appetite or activity, seizure, muscle pain, shivering, stiff neck, pain when urinating, etc. in spite of any colour of the background light or absence of fever. Please consult your physician if the thermometer shows elevated temperature (yellow or red background lights). The operating ambient temperature range for this thermometer is 10  –  40  °C (50  –  104  °F). Do not expose the thermometer to extreme temperatures (below -25  °C / -13  °F or over 55  °C / 131  °F) or excessive humidity (>95% RH). This thermometer must only be used with genuine Braun ThermoScan disposable Hygiene caps (LF 40). To avoid inaccurate measurements ALWAYS use this thermometer with a new, clean Hygiene cap attached. If the thermometer is accidentally used without a Hygiene cap attached, clean the lens (see «Care and cleaning» section). Keep Hygiene caps out of reach of children
• CW999

  section). Keep Hygiene caps out of reach of children. DO NOT modify this equipment without authorization of the manufacturer. Parents/guardians should call the pediatrician upon noticing any unusual sign(s) or symptom(s). For example, a child who exhibits irritability, vomiting, diarrhea, dehydration, seizure, changes in appetite or activity, even in the absence of fever, or who exhibits a low temperature, may still need to receive medical attention.Children who are on antibiotics, analgesics, or antipyretics should not be assessed solely on temperature readings to determine the severity of their illness.Temperature elevation as indicated by Age Precision™ Technology may signal a serious illness, especially in adults who are old, frail, have a weakened immune system, or neonates and infants. Please seek professional advice immediately when there is a temperature elevation and if you are taking temperature on: • neonates and infants under 3 months (consult your doctor immediately if the temperature exceeds 37.4 °C or 99.4 °F) • Individuals over 60 years of age • Individuals having diabetes mellitus or a weakened immune system (e.g., HIV positive, cancer chemotherapy, chronic steroid treatment, splenectomy) • Individuals who are bedridden (e.g., nursing home patient, stroke, chronic illness, surgical recovery)• a transplant recipient (e.g., liver, heart, lung, kidney) Fever may be blunted or even absent in elderly patients. This thermometer contains small parts that can be swallowed or produce a choking hazard to children. Always keep the thermometer out of children’s reach

Primary placement in Belgium; available across 12 countries total.

Trade name

Braun ThermoScan 7+ Connect, IRT6575NWE

UDI-DI code

07630759301054

Basic UDI-DI

76307593IR6000GH

Reference / catalog number

IRT6575NWE

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Infrared Ear thermometer

Additional information URL

https://www.helenoftroy.com/emea/

Clinical sizes

• Patients having ages ranging from normal weight (full term) new-born to geriatric adult

• V0301010201CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES)

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