DEVICE: PFM (05099169439832)
Device Identifier (DI) Information
PFM
4300
In Commercial Distribution
VITALOGRAPH (IRELAND) LIMITED
4300
In Commercial Distribution
VITALOGRAPH (IRELAND) LIMITED
4300 PEAK FLOW METER myPEF SWITZERLAND
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
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No | |
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? |
---|---|---|---|---|
46872 | Peak flow meter, manual |
A manual, hand-held instrument designed to measure only the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] from the lungs. It typically includes a tube for patient exhalation, an easy-to-grip handle, and a calibrated scale that shows the value of the peak flow. The device helps to discriminate the pulmonary status in routine tests performed in or outside of a clinical setting; it is also intended for periodic self-evaluation of the respiratory status of a patient, and to help in the treatment evaluation of patients suffering from chronic respiratory disorders (e.g., asthma, emphysema).
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BXW | CALIBRATOR, VOLUME, GAS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K781922 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 0 and 50 Degrees Celsius |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
238de9d5-feee-4922-bd14-c5cf3c8570dd
July 06, 2018
3
December 08, 2016
July 06, 2018
3
December 08, 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 |
---|---|---|---|---|---|
35099169439833 | 25 | 05099169439832 | In Commercial Distribution | ||
55099169439837 | 40 | 35099169439833 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined