Duns Number:203298203
Device Description: Compressor Air Filter Replacements to be used with OMBRA Compressor
Catalog Number
10554494001
Brand Name
OMBRA Compressor Air Filters
Version/Model Number
105544
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 2020
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131881,K131881
Product Code
BTI
Product Code Name
Compressor, Air, Portable
Public Device Record Key
77f3de87-839e-45b8-93a9-9c0823f0cdd7
Public Version Date
April 23, 2020
Public Version Number
5
DI Record Publish Date
September 30, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 21 |