Duns Number:088302096
Catalog Number
26849-FRU
Brand Name
Oxygen Fitting, DISS with Female Q/C
Version/Model Number
26849-FRU
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
February 15, 2099
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BXY
Product Code Name
Flowmeter, Calibration, Gas
Public Device Record Key
7dc97d6f-7d15-40a4-b07e-e0e4a7540790
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 15, 2019
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 | 344 |
2 | A medical device with a moderate to high risk that requires special controls. | 192 |