DEVICE: Oval Silicone ResuscitatorPediatric (05707480039807)

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Device Identifier (DI) Information

Oval Silicone ResuscitatorPediatric
370002000
370002000
Ambu A/S
05707480039807
GS1
1
Ambu Oval Silicone Resuscitator, Pediatric. Complete with patient valve, pressure limiting valve, O2 reservoir bag and open cuff silicone face mask size 1.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Pulmonary resuscitator, manual, reusable A hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
BTM Ventilator, emergency, manual (resuscitator)
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -40 and 60 Degrees Celsius
Handling Environment Temperature: between -18 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Pediatric
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Device Status

In Commercial Distribution
December 19, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05707480039814 12 05707480039807 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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+14107686464
Purchase_orders@ambuUSA.com
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