DEVICE: PFM (05099169439917)

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Device Record History
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Device Identifier (DI) Information
PFM
4300
In Commercial Distribution

VITALOGRAPH (IRELAND) LIMITED
05099169439917
GS1

1
219683489 *Terms of Use
4300 PEAK FLOW METER
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
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).
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
BXW CALIBRATOR, VOLUME, GAS
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K781922 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
d2a6f05b-6f52-44ca-bb9e-579d27813b62
July 06, 2018
3
December 08, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
35099169439918 25 05099169439917 In Commercial Distribution
55099169439912 40 35099169439918 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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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