DEVICE: Spirotrac (65099169686757)

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Device Record History
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Device Identifier (DI) Information
Spirotrac
7000
In Commercial Distribution

VITALOGRAPH (IRELAND) LIMITED
65099169686757
GS1

1
219683489 *Terms of Use
68675 software
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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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BZG SPIROMETER, DIAGNOSTIC
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K141546 000
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
2c8450d3-7e2d-4274-a8ca-35a7919b5f9c
March 08, 2022
5
December 14, 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
05099169706088 1 15099169676784 In Commercial Distribution
15099169676784 15 65099169686757 In Commercial Distribution
15099169676791 15 65099169686757 In Commercial Distribution
05099169706095 1 15099169676791 In Commercial Distribution
05099169706118 1 15099169676814 2017-01-26 Not in Commercial Distribution
15099169676814 15 65099169686757 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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