Duns Number:184763290
Catalog Number
PM6060/A
Brand Name
Pressure Monitor Tubing
Version/Model Number
00884450569306
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
FPK
Product Code Name
Tubing, fluid delivery
Public Device Record Key
0daa4d23-6bda-437b-8f9b-4d6709e0ad68
Public Version Date
August 22, 2022
Public Version Number
1
DI Record Publish Date
August 12, 2022
Package DI Number
20884450569300
Quantity per Package
4
Contains DI Package
10884450569303
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 | 573 |
2 | A medical device with a moderate to high risk that requires special controls. | 8779 |