Duns Number:227246220
Catalog Number
-
Brand Name
6051-0000-217
Version/Model Number
6051-0000-217
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 21, 2019
Issuing Agency
In HIBCC
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
-
Product Code
CCL
Product Code Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Public Device Record Key
511d4200-b763-418d-8a77-eac979c47cef
Public Version Date
December 30, 2019
Public Version Number
5
DI Record Publish Date
September 20, 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. | 14 |