DEVICE: INCENTIVE SPIROMETER,5000ML (04716770935003)
Device Identifier (DI) Information
INCENTIVE SPIROMETER,5000ML
TB-93500
In Commercial Distribution
BESMED HEALTH BUSINESS CORP.
TB-93500
In Commercial Distribution
BESMED HEALTH BUSINESS CORP.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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31266 | Incentive spirometer |
A hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility and in the home. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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BWF | Spirometer, Therapeutic (Incentive) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K141355 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3f478f23-5081-4185-a99a-ee31d32da15c
November 17, 2023
4
September 06, 2016
November 17, 2023
4
September 06, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined