DEVICE: Rotationsflowgeber Set (04057155000320)

Device Identifier (DI) Information

Rotationsflowgeber Set
Rotationsflowgeber Set
In Commercial Distribution

eResearchTechnology GmbH
04057155000320
GS1

1
341625331 *Terms of Use
Set of three rotary flow sensors for single-patient use, accessory to Asthma Monitor
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Peak flow meter, electronic A battery-powered, hand-held 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 personal computer (PC). The device is typically intended to monitor the respiratory status of a patient suffering from chronic respiratory disease (e.g., asthama, emphysema) in a clinical setting or the home.
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FDA Product Code

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Product Code Product Code Name
BZG Spirometer, Diagnostic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K090486 000
K092890 000
K133722 000
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Sterilization

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

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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

4d9a587c-c03e-48df-bf72-217ab15c9b59
July 06, 2018
3
July 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
1800 7049698
CustomerCare@ert.com
+4993057209891
CustomerCare@ert.com
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