BABY START

Organization name

GINEVRI srl

SRN

IT-MF-000034527

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 32 countries total.

Trade name

BABY START

UDI-DI code

08053847360112

Basic UDI-DI

B-08053847360112

Reference / catalog number

7236

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The Baby Start is a manual resuscitator suitable for delivery rooms, post-partum, special units for the care of newborns and Neonatal Intensive Care Units. It is a tool to resuscitate asphyxiated newborns using a mask or endotracheal tube. Resuscitation is carried out under positive pressure with manual control and free exhalation. The mixture flows into the lungs at pressures adjustable by the operator. The use of the T-fitting can achieve the desired PIP and determine the constant PEEP to help create FRC and improve lung tidal volume. Resuscitation pressures (PIP and PEEP) are indicated on aneroid bronchomanometer with fast response and easy reading. Above the chosen maximum pressure value (PIP), the built-in "max pressure" safety valve is activated to prevent the danger of excessive inspiratory pressures. The manual control is obtained by obstructing, with a finger, the PEEP valve, placed on the resuscitation head. The mixture flows throughout the duration of the above indicated obstruction. The resuscitator works connected to a source of air, oxygen or mixture of both taken from Flowmeter Mixer or Blender that can be connected to a gas humidifier. The device uses a disposable circuit made with spiral tube complete with expiratory valve and neonatal mask or cannula.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 5 ÷ 15 L/m

European Medical Device Nomenclature — the EU product classification assigned to this device.

• R03020201MANUALLY OPERATED PULMONARY RESUSCITATORS