DEVICE: EASY GRIP (07540195000278)

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Device Identifier (DI) Information

EASY GRIP
01BM3511
01BM3511-CS
O-Two Medical Technologies Inc
07540195000278
GS1
1
The disposable Child EASY GRIP® Bag Valve Mask Resuscitator is a reusable device for manual ventilation. It is designed for use in various clinical settings to provide respiratory support to the respiratory distressed or non-breathing CHILD patient. When used with a supplemental oxygen supply, the device may provide 100% oxygen on every squeeze of the bag. The Child EASY GRIP resuscitator comes standard with a Pressure Relief Valve set at 40 cm H2O which can be overridden by the operator.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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, single-use A non-sterile, 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 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 single-use 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

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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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
October 26, 2015

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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
17540195000275 12 07540195000278 In Commercial Distribution Corrugated carton
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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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None
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Production Identifier(s) in UDI

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Customer Contact

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1-800-387-3405
cs@otwo.com
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