DEVICE: N/A (00607411301216)
Device Identifier (DI) Information
N/A
1111
In Commercial Distribution
1111
SALTER LABS
1111
In Commercial Distribution
1111
SALTER LABS
Comfort Face Tent with 42” Aerosol Tubing
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
35172 | Aerosol face mask, non-rebreathing |
A flexible, form-shaped device that is placed over the nose and mouth to deliver air, oxygen (O2), or a mixture of the two gases, with aerosolized particles, to a patient's airway. It includes two unidirectional valves, one that closes during inspiration to prevent room air from mixing with the O2 in the reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It typically includes a headstrap and is available in a range of sizes. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BYG | MASK, OXYGEN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -40 and 60 Degrees Celsius |
Special Storage Condition, Specify: N/A |
Handling Environment Temperature: between 5 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Adult |
Device Record Status
9e324bac-f6af-4511-8b78-6308670f4147
March 29, 2018
2
November 30, 2016
March 29, 2018
2
November 30, 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 |
---|---|---|---|---|---|
10607411301213 | 50 | 00607411301216 | In Commercial Distribution |
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)421-0024
customercare@salterlabs.com
customercare@salterlabs.com