DEVICE: Newtowne Hyperbarics (00856439000263)

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Device Identifier (DI) Information

Newtowne Hyperbarics
Class 7

TYPHOON WATER WARES LTD
00856439000263
GS1
1
Class 7 portable hyperbaric chamber.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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
Hyperbaric chamber, portable A non-powered, portable device consisting of a large bag intended to contain a patient and to be inflated above ambient atmospheric pressure for the treatment of acute mountain sickness. The bag is inflated using a foot pump or air compressor, the internal pressure being controlled by an inlet/deflation valve; it is not intended to be used with enriched oxygen. The device is typically used by mountain climbers and athletes who train at high elevation. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
CBF Chamber, Hyperbaric
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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
Special Storage Condition, Specify: Away from sources of heat and chemicals.
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Clinically Relevant Size

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Size Type Text
Length: 104 Inch
Outer Diameter: 34 Inch
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Device Status

In Commercial Distribution
April 30, 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
Yes
No
No
No CLOSE

Customer Contact

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410-575-4220
sales@newtownehyperbarics.com
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