DEVICE: DeVilbiss (00085304001508)
Device Identifier (DI) Information
DeVilbiss
3655PL-JCMH
In Commercial Distribution
3655PL-JCMH
DEVILBISS HEALTHCARE LLC
3655PL-JCMH
In Commercial Distribution
3655PL-JCMH
DEVILBISS HEALTHCARE LLC
Compressor / Nebulizer JCMH Home Health Products
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Medical device air compressor | A mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAF | Nebulizer (Direct Patient Interface) |
BTI | Compressor, Air, Portable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K020932 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit |
Handling Environment Humidity: less than 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
3a180883-dae7-4011-a897-0196abb23655
July 06, 2018
3
September 09, 2016
July 06, 2018
3
September 09, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10885430400150 | 6 | 00085304001508 | In Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-338-1988
somdhccustomerservice@devilbisshc.com
somdhccustomerservice@devilbisshc.com