DEVICE: Airzone (05023323001214)
Device Identifier (DI) Information
Airzone
3130045
In Commercial Distribution
3130045
CLEMENT CLARKE INTERNATIONAL LIMITED
3130045
In Commercial Distribution
3130045
CLEMENT CLARKE INTERNATIONAL LIMITED
AIRZONE BLUE ATS (US) SINGLE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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? |
---|---|---|---|---|
65366 | Expiratory peak flow meter, analogue, reusable |
A 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 is in the form of a cylinder with a mouthpiece for exhalation, and a calibrated analogue scale that shows the peak flow value. The device helps to assess pulmonary function in routine tests performed in or outside 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 affected by chronic respiratory disorders (e.g., asthma, emphysema). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BZH | Meter, Peak Flow, Spirometry |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
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
c0809e9e-b959-40a3-9bf1-6f6810e8130f
March 27, 2023
3
September 07, 2016
March 27, 2023
3
September 07, 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 |
---|---|---|---|---|---|
05023323001535 | 10 | 05023323001214 | 2023-03-24 | Not in Commercial Distribution | |
05023323001542 | 10 | 05023323001535 | 2023-03-24 | Not in Commercial Distribution | |
05023323002266 | 10 | 05023323001214 | In Commercial Distribution | ||
05023323002273 | 10 | 05023323002266 | 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
[?]
+4401279414969
twhay@ccholdingsltd.com
twhay@ccholdingsltd.com