DEVICE: AEROCHAMBER mini Holding Chamber (00762860875012)

Device Identifier (DI) Information

AEROCHAMBER mini Holding Chamber
87501
In Commercial Distribution

Trudell Medical International
00762860875012
GS1

1
203298203 *Terms of Use
62860875010029
AEROCHAMBER mini Holding Chamber
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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?
35122 Metered dose inhaler
A hand-held device designed to administer a pre-measured dose of aerosolized medication directly into the mouth of a patient. It typically consists of a shaped plastic holder with integrated mouthpiece into which a pressurized metal canister containing the solution or suspension of medicine is placed. Commonly known as a metered dose inhaler (MDI), aerosol inhaler or puffer, it is a portable device typically carried in the pocket or a handbag (purse) of the patient for convenient access. A medicine chamber spacer may be attached to this device to facilitate its use by small children (enables the slow inhalation of the medicine). This is a reusable device intended for single-patient use.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAF Nebulizer (Direct Patient Interface)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K090065 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

195dbe20-d735-4a5c-81c8-b0211f02e434
February 26, 2020
1
February 18, 2020
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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
10762860875019 10 00762860875012 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
No
No
No CLOSE

Customer Contact

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