Duns Number:050579217
Device Description: Not required for BLA products.
Catalog Number
301175
Brand Name
Procleix
Version/Model Number
Procleix System Fluid Preservative
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MZA
Product Code Name
TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN
Public Device Record Key
95bbe532-bcb2-4a13-ba95-180890b064e5
Public Version Date
January 01, 2020
Public Version Number
4
DI Record Publish Date
August 06, 2014
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 | 130 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 311 |
| 3 | A medical device with high risk that requires premarket approval | 96 |