DEVICE: SmartVest (B102060710S2150)

Device Identifier (DI) Information

SmartVest
SV-36-AS-PC
In Commercial Distribution
SV-36-AS-PC
ELECTROMED, INC.
B102060710S2150
HIBCC

1
036514250 *Terms of Use
LTU SmartVest® – Adult Small (PK Camo)
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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
Chest-oscillation airway secretion clearing system vest A tightly-fitting garment-like device that is a component of a high frequency chest wall oscillation airway secretion-clearing system and which is worn to encompass the thorax of a patient during high frequency chest wall oscillation (HFCWO) treatment. It is connected via a dedicated thick-walled hose to the system's generator which rapidly inflates and deflates the vest against the chest wall to promote airway clearance by creating HFCWO resulting in the mobilization of bronchial secretions. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
BYI Percussor, Powered-Electric
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

4fa81f65-b622-49e5-8ed5-f58ab0bc058d
March 29, 2018
2
September 23, 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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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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