Duns Number:796083392
Device Description: D300-2011 E-Z Draw Sample Port
Catalog Number
-
Brand Name
E-Z Draw Sample Port
Version/Model Number
D300-2011
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
f18e5b78-5150-4170-b8d6-b0f235554893
Public Version Date
April 14, 2021
Public Version Number
1
DI Record Publish Date
April 06, 2021
Package DI Number
00858293006854
Quantity per Package
100
Contains DI Package
00858293006847
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 |