DEVICE: VIBRALUNG® (00709078002410)

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Device Record History
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Device Identifier (DI) Information
VIBRALUNG®
9641
In Commercial Distribution

WESTMED, INC.
00709078002410
GS1

1
092673953 *Terms of Use
VIBRALUNG® HHT Hanger
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
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Yes
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No
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No

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?
45335 Electroacoustical airway secretion-clearing system
An assembly of devices designed to provide externally applied vibrations to the chest wall of a patient via an electroacoustical transducer (the applicator) to loosen excessive airway secretions [mucus or sputum (phlegm)] to promote airway clearance and improve bronchial drainage for patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)]. It consists of a mains electricity (AC-powered) frequency generator, a hand-held applicator containing the transducer, and connecting cable. It is intended to be operated by a healthcare professional in a professional setting.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BYI Percussor, Powered-Electric
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K133057 000
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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
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 70 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
9b3f9d38-3792-4a98-8c7e-db5d7560d63d
July 06, 2018
3
October 19, 2017
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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
10709078002417 25 00709078002410 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
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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