Duns Number:028007698
Device Description: Confirm 4, Cutoff 10x50mL
Catalog Number
19582002-10pk
Brand Name
Detectabuse
Version/Model Number
19582002-10pk
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DIF
Product Code Name
Drug Mixture Control Materials
Public Device Record Key
732b7414-77a3-4f3f-b7e4-da53d63551c9
Public Version Date
January 20, 2020
Public Version Number
1
DI Record Publish Date
January 10, 2020
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 | 388 |