DEVICE: AEROBIKA OPEP with Manometer (00762860105041)

Device Identifier (DI) Information

AEROBIKA OPEP with Manometer
110504
In Commercial Distribution

Trudell Medical International
00762860105041
GS1

1
203298203 *Terms of Use
62860110504023
AEROBIKA OPEP with Manometer
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
Yes
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?
43947 Positive pressure airway secretion-clearing device
A hand-held, non-powered device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airways using positive pressure airway (PEP) to treat patients affected by acute or chronic lung disease. PEP is created when a patient exhales into the device which creates vibrations in the chest by various means (e.g., an oscillating ball or creating bubbles in a solution within the device) loosening the mucus for expectoration and assisting in lung expansion. Also known as an oscillating positive expiratory pressure (OPEP) device, it is a single-patient device designed for use both in a healthcare facility and in the home. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BWF Spirometer, Therapeutic (Incentive)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K150173 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

400ebfe9-5a91-4fbf-b8ea-20bb60a4288b
June 22, 2021
2
February 18, 2020
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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
10762860105048 10 00762860105041 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

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-519-455-4862
customerservice@trudellmed.com
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