Duns Number:203298203
Device Description: OMBRA Table Top Compressor System (120V)
Catalog Number
-
Brand Name
OMBRA 120V Table Top Compressor System
Version/Model Number
105510
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
K131881,K131881,K131881
Product Code
BTI
Product Code Name
Compressor, Air, Portable
Public Device Record Key
f0d40ade-f277-48c0-94a6-ed409b9781dd
Public Version Date
April 02, 2020
Public Version Number
1
DI Record Publish Date
March 25, 2020
Package DI Number
10762860055107
Quantity per Package
6
Contains DI Package
00762860055100
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |