Duns Number:796083392
Device Description: Sample Port
Catalog Number
-
Brand Name
E-Z Draw
Version/Model Number
D300-2012
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
-
Product Code
MON
Product Code Name
System, Hemodialysis, Remote Accessories
Public Device Record Key
e9b650ec-4a86-4eca-a3b1-4ecfa00da768
Public Version Date
October 21, 2020
Public Version Number
1
DI Record Publish Date
October 13, 2020
Package DI Number
00858293006830
Quantity per Package
1000
Contains DI Package
00858293006359
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 30 |
2 | A medical device with a moderate to high risk that requires special controls. | 46 |