DEVICE: Power Cord American Standard (06948538362785)

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Device Record History
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Device Identifier (DI) Information
Power Cord American Standard
/
In Commercial Distribution

BMC Medical Co., Ltd.
06948538362785
GS1

1
526010310 *Terms of Use
Power Cord American Standard
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Device Characteristics
Labeling does not contain MRI Safety Information
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Yes
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GMDN

[?]

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?
60712 Home BPAP unit
A portable mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using bi-level positive airway pressure (BPAP) during spontaneous respiration for adult/child (non-infant) patients affected by obstructive sleep apnoea (OSA) and/or to treat patients with conditions requiring respiratory assistance in the home [e.g., chronic obstructive pulmonary disease (COPD)]. It is a small desktop unit with controls, and may include a built-in humidifier. The device is intended for use in the home but may also be used in healthcare facilities.
Active false
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FDA Product Code

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Product Code Product Code Name
BZD Ventilator, Non-Continuous (Respirator)
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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
No
No
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
b53cc202-a1c5-4e57-b8df-81b5b106a7f7
November 10, 2022
2
September 15, 2022
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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
16948538362782 100 06948538362785 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
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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