DEVICE: Spirotrac (65099169686740)
Device Identifier (DI) Information
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? |
|---|---|---|---|---|
| 13680 | Diagnostic spirometer, professional |
An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.
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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 [?] |
|---|---|
| K141546 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
a0dd213a-f7f4-4f0e-8eab-e0d6545b6df0
March 08, 2022
5
December 14, 2016
March 08, 2022
5
December 14, 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 |
|---|---|---|---|---|---|
| 15099169676760 | 15 | 65099169686740 | Not in Commercial Distribution | ||
| 05099169706064 | 1 | 15099169676760 | 2017-01-26 | Not in Commercial Distribution | |
| 15099169676814 | 15 | 65099169686740 | In Commercial Distribution | ||
| 05099169706118 | 1 | 15099169676814 | In Commercial Distribution | ||
| 15099169676777 | 15 | 65099169686740 | In Commercial Distribution | ||
| 05099169706071 | 1 | 15099169676777 | In Commercial Distribution | ||
| 05099169706057 | 1 | 15099169676753 | 2017-01-26 | Not in Commercial Distribution | |
| 15099169676753 | 15 | 65099169686740 | Not in Commercial Distribution | ||
| 05099169706040 | 1 | 15099169676746 | 2017-01-26 | Not in Commercial Distribution | |
| 05099169706026 | 1 | 15099169676722 | 2017-01-26 | Not in Commercial Distribution | |
| 15099169676746 | 15 | 65099169686740 | Not in Commercial Distribution | ||
| 05099169706125 | 1 | 15099169676821 | 2017-01-26 | Not in Commercial Distribution | |
| 15099169676821 | 15 | 65099169686740 | Not in Commercial Distribution | ||
| 15099169676722 | 15 | 65099169686740 | Not in Commercial Distribution | ||
| 15099169676852 | 15 | 65099169686740 | In Commercial Distribution | ||
| 15099169676715 | 15 | 65099169686740 | In Commercial Distribution | ||
| 05099169706156 | 1 | 15099169676852 | 2017-01-26 | Not in Commercial Distribution | |
| 05099169706019 | 1 | 15099169676715 | In Commercial Distribution | ||
| 05099169706194 | 1 | 15099169676890 | In Commercial Distribution | ||
| 15099169676890 | 15 | 65099169686740 | 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