DEVICE: Model 4000 (15099169402765)
Device Identifier (DI) Information
Model 4000
4000
In Commercial Distribution
VITALOGRAPH (IRELAND) LIMITED
4000
In Commercial Distribution
VITALOGRAPH (IRELAND) LIMITED
4000 RESPIRATORY MONITOR COPD-6 NEW ZEALAND
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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| No | |
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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? |
|---|---|---|---|---|
| 46906 | Expiratory peak flow meter, digital |
A battery-powered, hand-held, electronic instrument designed to measure the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] and forced expiratory volume (FEV) from the lungs. It typically includes a mouthpiece for patient exhalation and a digital display [e.g., liquid-crystal display (LCD)]; it may include a port for communicating with a computer/tablet. The device is typically intended to monitor the respiratory status of a patient affected by chronic respiratory disorders (e.g., asthma, emphysema) in a clinical setting or the home.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| BZG | SPIROMETER, DIAGNOSTIC |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K073155 | 000 |
Sterilization
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 |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
8945182c-d3da-486b-919e-b03c733d4be1
March 19, 2021
4
December 08, 2016
March 19, 2021
4
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 |
|---|---|---|---|---|---|
| 35099169402769 | 25 | 05099169402768 | In Commercial Distribution | ||
| 05099169402768 | 1 | 15099169402765 | In Commercial Distribution |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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