Duns Number:036623932
Catalog Number
-
Brand Name
Quick Stat Liquid Bulk Syringe
Version/Model Number
504155
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
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
MVL
Product Code Name
Cord, Retraction
Public Device Record Key
e2d4d9c6-dc03-4d26-8dcc-ca2b4f5961dd
Public Version Date
December 06, 2021
Public Version Number
2
DI Record Publish Date
January 20, 2021
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 | 316 |
2 | A medical device with a moderate to high risk that requires special controls. | 144 |
U | Unclassified | 36 |