DEVICE: GaleMed (04710810085161)

Device Identifier (DI) Information

GaleMed
71024
In Commercial Distribution

GaleMed Xiamen Co., Ltd.
04710810085161
GS1

1
527333326 *Terms of Use
Disposable Tee Valve
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Non-rebreathing valve, single-use A non-sterile device containing a one-way valve intended to be used to direct the flow of breathing gases, typically in a breathing circuit or between an oxygen mask and its reservoir bag, to prevent patient rebreathing of exhaled gases. The device is available in various designs and includes unidirectional valves made of various materials (e.g., silicone, rubber, metal, or mica sheets/discs) that typically open and close with each inspiration/expiration. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
BZA Connector, Airway (Extension)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -40 and 60 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

9c20b96d-046b-41f7-823f-81f5eb23ee6e
March 29, 2018
2
September 19, 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
44710810085169 100 04710810085161 In Commercial Distribution 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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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