DEVICE: SmartVest (B102090535S0100)

Device Identifier (DI) Information

SmartVest
SQL-MAINT
In Commercial Distribution
SQL-MAINT
ELECTROMED, INC.
B102090535S0100
HIBCC

1
036514250 *Terms of Use
SQL® Filter & Fuse Maintenance Kit
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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 generator A mains electricity (AC-powered) component of a high frequency chest wall oscillation airway secretion-clearing system that produces oscillating pressurized air-pulses that are delivered to an inflatable vest via a dedicated thick-walled hose. The air-pulses cause the vest to rapidly inflate and deflate against the chest wall of the patient promoting airway clearance by creating high frequency chest wall oscillation (HFCWO) resulting in the mobilization of bronchial secretions.
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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
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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

f388c6c3-2783-4dc0-9368-f5378f72f293
March 29, 2018
2
September 19, 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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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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