Duns Number:485050483
Device Description: Transducer Protector Hydrophobic Vent Filter (female and male slip luer)
Catalog Number
6254185
Brand Name
Pall
Version/Model Number
6254185
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
K910821,K910821
Product Code
FIB
Product Code Name
PROTECTOR, TRANSDUCER, DIALYSIS
Public Device Record Key
5691c7df-882a-4948-a675-83b0604adadc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 21, 2015
Package DI Number
35034480315107
Quantity per Package
50
Contains DI Package
05034480315106
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |