Duns Number:360551766
Catalog Number
-
Brand Name
DK50 DS
Version/Model Number
STA NOZ 115V/60Hz 3bar NO
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K091871
Product Code
BTI
Product Code Name
Compressor, Air, Portable
Public Device Record Key
c2a91cef-7126-4d14-b06c-1f7092912b5a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 26, 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. | 91 |