DEVICE: Go-PAP (00841470111601)

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Device Record History
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Device Identifier (DI) Information
Go-PAP
313-4600
In Commercial Distribution

PULMODYNE INC
00841470111601
GS1

1
030619483 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
64811 In-line CPAP gas flow management unit, non-adjustable
A portable non-electronic device intended to mix ambient air with compressed oxygen (O2) to generate a flow of oxygen rich air to a patient at a pre-set (non-adjustable) inspired oxygen concentration (FiO2) [e.g., pre-set at 28-33%], for continuous positive airway pressure (CPAP) with oxygen, during noninvasive and invasive ventilation (i.e., capable of both). Also known as a CPAP flow generator, it includes an oxygen supply connection, ambient air inlet, and a patient outlet; it does not include any controls. CPAP pressure is defined by the PEEP valve used with this device. This is a reusable device.
Active false
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FDA Product Code

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Product Code Product Code Name
BYE Attachment, Breathing, Positive End Expiratory Pressure
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
864a2d0e-25fa-410b-848a-d4a92d9ff6f4
April 21, 2025
1
April 12, 2025
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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
10841470111608 10 00841470111601 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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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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