Duns Number:184763290
Catalog Number
PM6036/A
Brand Name
Pressure Monitor Tubing
Version/Model Number
00884450569283
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
e2f2d750-95b9-4b4b-a16c-70bf35e70fa1
Public Version Date
May 13, 2022
Public Version Number
1
DI Record Publish Date
May 05, 2022
Package DI Number
20884450569287
Quantity per Package
4
Contains DI Package
10884450569280
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 |