Duns Number:180572216
Device Description: Blood Collection Set, 21G X 3/4, 12" tubing
Catalog Number
26764
Brand Name
Exel Vaculet Blood Collection Set
Version/Model Number
26764
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"
Yes
For Single-Use
Yes
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
139dad22-3a89-4ce4-b38c-3a94038a4112
Public Version Date
July 23, 2020
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
20020221267642
Quantity per Package
4
Contains DI Package
10020221267645
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 21 |
2 | A medical device with a moderate to high risk that requires special controls. | 82 |