DEVICE: DeVilbiss (00885304008873)

Device Identifier (DI) Information

DeVilbiss
7305P-D-EXF
In Commercial Distribution
7305P-D-EXF
DEVILBISS HEALTHCARE LLC
00885304008873
GS1

1
962175894 *Terms of Use
Homecare Suction, North America with 800CC bottle with External Filter and Rechargeable Battery
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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?
10749 Airway suction catheter
A flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K982304 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

394559fd-3845-4682-83cf-5dbb453ec892
November 04, 2024
5
September 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
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
1-800-338-1988
somdhccustomerservice@devilbisshc.com
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