Duns Number:088302096
Catalog Number
28657-FRU
Brand Name
FRU, Axess Accessory Kit, White
Version/Model Number
28657-FRU
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 14, 2199
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
K033503
Product Code
CBN
Product Code Name
Apparatus, Gas-Scavenging
Public Device Record Key
4bea677c-0e76-46f2-ae46-2fd03dec9860
Public Version Date
January 14, 2019
Public Version Number
1
DI Record Publish Date
December 14, 2018
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 |