DEVICE: Res-Cue Key Refill-Pack (05707480031368)

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Device Identifier (DI) Information

Res-Cue Key Refill-Pack
248001000
248001000
Ambu A/S
05707480031368
GS1
1
Rescue Key, Refill Pack
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

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
Cardiopulmonary resuscitation mask, single-use A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. 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

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

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Storage and Handling
Handling Environment Temperature: between -18 and 50 Degrees Celsius
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
January 07, 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
05707480114757 24 05707480114764 In Commercial Distribution
05707480114764 50 05707480031368 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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