Duns Number:022721133
Device Description: Salter AIRE Elite™ Compressor replacement filters
Catalog Number
8501-0-5
Brand Name
Salter AIRE Elite
Version/Model Number
8501-0-5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K870027
Product Code
CCQ
Product Code Name
NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
Public Device Record Key
b8a07b48-3867-4ce9-917b-b8218ca7a164
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
February 09, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 865 |
2 | A medical device with a moderate to high risk that requires special controls. | 1134 |