DEVICE: Resuscitation Unit 104 E type (Stand-alone type) (04942962609821)

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Device Identifier (DI) Information

Resuscitation Unit 104 E type (Stand-alone type)
60982
60982
ATOM MEDICAL CORPORATION
04942962609821
GS1
1
No description.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Respiratory oxygen therapy system An assembly of devices designed to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at dfferent concentrations (e.g., via a gas mixer), duration of use, and flows. It will connect to an oxygen source and will typically include a flowmeter or flow controlling device, masks, tubing, valves, and/or nasal cannulae. It can also include, e.g., a high pressure gas reduction valve(s) and a pneumatically-powered suction device with collection bottle.
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FDA Product Code

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Product Code Product Code Name
BTL Ventilator, Emergency, Powered (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 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Height: 370 Millimeter
Width: 200 Millimeter
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Device Status

In Commercial Distribution
September 21, 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
No Package DIs found
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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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No
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No
Yes
No CLOSE

Customer Contact

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9999999999
matsumoto@atom-ami.co.jp
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